ID

37253

Description

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Keywords

Versions (1)
  1. 7/12/19 7/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 12, 2019

DOI

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License

Creative Commons BY-NC 3.0
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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

English

Screen

1 forms  
  1. StudyEvent: ODM
    1. Screen
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnic group

Data type

text

Alias
UMLS CUI [1]
C0015031
Race
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure - Systolic
Description

Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure - Diastolic
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Residual Toxicities Related to Previous Therapy for Ovarian Cancer
Description

Residual Toxicities Related to Previous Therapy for Ovarian Cancer

Alias
UMLS CUI-1
C0029925
UMLS CUI-2
C1514463
UMLS CUI-3
C0013221
Does the subject have any residual toxicities related to previous therapy for ovarian cancer?
Description

Ovarian Carcinoma, Prior Therapy, Drug toxicity

Data type

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0013221
Diagnosis Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Description

Ovarian Carcinoma, Prior Therapy, Drug toxicity, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0013221
UMLS CUI [1,4]
C0011900
NCI CTCAE v.3 Toxicity Grade
Description

Ovarian Carcinoma, Prior Therapy, Drug toxicity, Toxicity Grade

Data type

text

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0013221
UMLS CUI [1,4]
C2826262
Cancer Related Current Medical Conditions
Description

Cancer Related Current Medical Conditions

Does the subject have any cancer related current medical conditions?
Description

Current Medical Status, Due to, Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0006826
Diagnosis Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Description

Current Medical Status, Due to, Malignant Neoplasms, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C0011900
NCI CTCAE v.3 Toxicity Grade
Description

Current Medical Status, Due to, Malignant Neoplasms, Toxicity Grade

Data type

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C2826262
Non-Cancer Related Current Medical Conditions
Description

Non-Cancer Related Current Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0521116
Does the subject have any non-cancer related current medical conditions?
Description

Disease, Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
Diagnosis Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Description

Disease, Current, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0011900
NCI CTCAE v.3 Toxicity Grade
Description

Disease, Current, Toxicity Grade

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C2826262
Disease Characteristics
Description

Disease Characteristics

Alias
UMLS CUI-1
C0029925
UMLS CUI-2
C0599878
Primary Tumour Type at Initial Diagnosis
Description

Primary Tumor, Type, at initial diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C4071762
Date of Initial Diagnosis
Description

Primary Tumor, Date of diagnosis

Data type

date

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C2316983
Stage at Initial Diagnosis
Description

Primary Tumor, Tumor Stage, at initial diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1300072
UMLS CUI [1,3]
C4071762
Histology at Initial Diagnosis
Description

Primary Tumor, Histology, at initial diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0019638
UMLS CUI [1,3]
C4071762
Histological Grade at Initial Diagnosis
Description

Primary Tumor, Histopathologic Grade, at initial diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0919553
UMLS CUI [1,3]
C4071762
Date of Last Recurrence
Description

Primary Tumor, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0806020
Local Laboratory (Previous CA-125 Values - Including First-Line Treatment to Present) - Multiple Assessments
Description

Local Laboratory (Previous CA-125 Values - Including First-Line Treatment to Present) - Multiple Assessments

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0006610
Laboratory Name
Description

Performing laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Address
Description

Performing laboratory, Street Address

Data type

text

Alias
UMLS CUI [1,1]
C1882331
UMLS CUI [1,2]
C1301826
Lab ID
Description

Laboratory Identifier

Data type

text

Alias
UMLS CUI [1]
C2986056
Date Sample Taken
Description

Laboratory Procedures, CA-125 Antigen, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0006610
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
CA-125
Description

Laboratory Procedures, CA-125 Antigen, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0006610
UMLS CUI [1,3]
C1274040
Prior Cancer Related Surgical Procedures
Description

Prior Cancer Related Surgical Procedures

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C0205156
UMLS CUI-3
C2826292
Has the subject had prior surgery for the cancer under study?
Description

Operative Surgical Procedure, Previous, Related to Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2826292
Specific Procedure Record only one per line for each specific procedure
Description

Operative Surgical Procedure, Previous, Related to Cancer

Data type

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2826292
Date of Procedure
Description

Operative Surgical Procedure, Previous, Related to Cancer, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2826292
UMLS CUI [1,4]
C0011008
Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biologic Therapy
Description

Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biologic Therapy

Alias
UMLS CUI-1
C0920425
UMLS CUI-2
C0205156
Has the subject received prior chemotherapy, hormonal, immunotherapy, and/or biologic therapy for the cancer under study?
Description

Cancer Treatment, Previous, Chemotherapy; Cancer Treatment, Previous, Hormone Therapy; Cancer Treatment, Previous, Immunotherapy; Cancer Treatment, Previous, Biological treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0279025
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0021083
UMLS CUI [4,1]
C0920425
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C1531518
Drug Name
Description

Cancer Treatment, Previous, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2360065
Regimen Sequence
Description

Cancer Treatment, Previous, Chemotherapy Regimen, Sequence Number

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C2348184
Therapy Type
Description

Cancer Treatment, Previous, Type

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332307
Drug Administration Specifics - Number of Cycles/ Doses
Description

Cancer Treatment, Previous, Cycles, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1302181
UMLS CUI [1,4]
C0237753
Drug Administration Specifics - Units
Description

Cancer Treatment, Previous, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1519795
Drug Administration Specifics - Scheduled Dose
Description

Cancer Treatment, Previous, Dosage, Scheduled

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205539
Drug Administration Specifics - Dose Units
Description

Cancer Treatment, Previous, Dosage, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1519795
Intent
Description

Cancer Treatment, Previous, Reason

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0566251
Start Date
Description

Cancer Treatment, Previous, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0808070
Stop Date
Description

Cancer Treatment, Previous, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0806020
Best Response
Description

Cancer Treatment, Previous, Best Overall Response

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2986560
Duration of Response
Description

Cancer Treatment, Previous, Response Duration

Data type

integer

Measurement units
  • weeks
Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0237585
Lesion Assessment Using WHO Criteria - Indicator Lesions
Description

Lesion Assessment Using WHO Criteria - Indicator Lesions

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1522602
UMLS CUI-3
C0220825
Lesion No.
Description

Lesion, Indicator, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0237753
Anatomic Description - Organ Code
Description

Lesion, Indicator, Organ, Code

Data type

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0805701
Anatomic Description - Lesion Location
Description

Lesion, Indicator, Location

Data type

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0450429
Date
Description

Lesion, Indicator, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0011008
Can lesion be measured?
Description

Lesion, Indicator, Measurement method

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C1299991
Diameter
Description

Lesion, Indicator, Diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C1301886
mm
Product
Description

Lesion, Indicator, Lesion size

Data type

integer

Measurement units
  • mm2
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0449453
mm2
Method
Description

Lesion, Indicator, Measurement method

Data type

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C1299991
Previously Irradiated
Description

Lesion, Indicator, Therapeutic radiology procedure, Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C1522449
UMLS CUI [1,4]
C0205156
Lesion Assessment Using WHO Criteria - Non-Measurable, Non-Evaluable Lesions
Description

Lesion Assessment Using WHO Criteria - Non-Measurable, Non-Evaluable Lesions

Alias
UMLS CUI-1
C1334988
UMLS CUI-2
C0220825
Lesion No.
Description

Non-Measurable Lesion, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0237753
Anatomic Description - Lesion Location
Description

Non-Measurable Lesion, Location

Data type

text

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0450429
Date
Description

Non-Measurable Lesion, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0011008
Present
Description

Non-Measurable Lesion, Present

Data type

text

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0150312
Absent
Description

Non-Measurable Lesion, Absent

Data type

text

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0332197
Not Done
Description

Non-Measurable Lesion, Not Done

Data type

text

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C1272696
Regimen
Description

Regimen

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C1276413
Check one
Description

Therapeutic procedure, Therapeutic regimen

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1276413
Eligibility Question - Dose-Finding Run-In
Description

Eligibility Question - Dose-Finding Run-In

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria for the dose-finding run-in phase?
Description

Eligibility Determination

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria - Dose-Finding Run-In
Description

Inclusion Criteria - Dose-Finding Run-In

Alias
UMLS CUI-1
C1512693
Subject has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer which was histologically confirmed at the time of the primary diagnosis.
Description

Epithelial ovarian cancer; Fallopian Tube Carcinoma; Primary peritoneal carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0677886
UMLS CUI [1,2]
C0238122
UMLS CUI [1,3]
C1514428
Subject is female ≥ 18 years of age with an ECOG Performance Status of 0, 1 or 2.
Description

Gender; Age; ECOG performance status

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C1520224
Subject has received one prior platinum-based chemotherapeutic regimen (containing either carboplatin or cisplatin) for the treatment of primary disease. Consolidation chemotherapy is not permitted.
Description

Chemotherapy Regimen, Platinum-based

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514162
Subject has potentially platinum-sensitive or platinum resistant disease.
Description

Platinum, Hypersensitivity; Platinum, Restistance

Data type

boolean

Alias
UMLS CUI [1,1]
C0032207
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0032207
UMLS CUI [2,2]
C1522618
Subject is allowed to have received, but is not required to have received, one additional prior non- cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction.
Description

Non-cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3898131
Subject has measurable or evaluable disease (CA-125 positive, > 40 units/dL, on two separate tests at least a week apart).
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Subject must have baseline laboratory values as follows: • Hemoglobin ≥ 9.0 g/dL • Neutrophils ≥ 1,500/mm3 • Platelets ≥ 100,000/mm3 • Creatinine ≤ 1.5 mg/dL (< 133 umol/l) or creatinine clearance ≥ 60 mL/min • Serum bilirubin ≤ 2.0 mg/dL (≤ 35 umol/L) • SGOT/AST, SGPT/ALT and alkaline phosphatase ≤ 2 times ULN if liver metastases are absent by abdominal CT or MRI or ≤ 5 times ULN if liver metastases are present.
Description

Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C1254595
Subjects of child-bearing potential must be practicing adequate contraception (e.g. oral contraceptives, diaphragm plus spermicide, or IUD) for at least 3 months prior to study start. The same contraceptive method should be used throughout the study and continue for at least 4 weeks after the end of the study. Note: Women will be considered of childbearing potential if not surgically sterile or post-menopausal (i.e. documented absence of menses for one year prior to entry into the study).
Description

Childbearing Potential, Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Eligibility Question - Phase 2 Activity Assessment
Description

Eligibility Question - Phase 2 Activity Assessment

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria for the phase 2 activity?
Description

Eligibility Determination

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria - Phase 2 Activity Assessment
Description

Inclusion Criteria - Phase 2 Activity Assessment

Alias
UMLS CUI-1
C1512693
Subject has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer which was histologically confirmed at the time of the primary diagnosis.
Description

Epithelial ovarian cancer; Fallopian Tube Carcinoma; Primary peritoneal carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0677886
UMLS CUI [1,2]
C0238122
UMLS CUI [1,3]
C1514428
Subject is female ≥ 18 years of age with an ECOG Performance Status of 0, 1 or 2.
Description

Gender; Age; ECOG performance status

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C1520224
Subject has received one prior platinum-based chemotherapeutic regimen (containing either carboplatin or cisplatin) for the treatment of primary disease. Consolidation chemotherapy is not permitted.
Description

Chemotherapy Regimen, Platinum-based

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514162
Subject’s disease is considered potentially platinum-sensitive (i.e., have had a platinum-free interval following complete response to carboplatin or cisplatin of greater than 6 months).
Description

Disease, Platinum, Sensitive

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0032207
UMLS CUI [1,3]
C0332324
Subject is allowed to have received, but is not required to have received, one additional prior non- cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction.
Description

Non-cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3898131
Subject must have at least one measurable lesion as determined by diagnostic studies including CT or MRI or physical exam. • Measurable disease on CT or MRI must have one diameter ≥ 1 cm and one diameter ≥ 2 cm, • Palpable tumor masses that cannot be evaluated radiologically must have 2 diameters ≥ 2 cm. An attempt to document lesion size by ultrasound should be undertaken for palpable lesions not visualized on CT (or MRI). The same diagnostic imaging method used to evaluate disease must be used throughout the study to evaluate lesions consistently.
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Subject must have baseline laboratory values as follows: • Hemoglobin ≥ 9.0 g/dL • Neutrophils ≥ 1,500/mm3 • Platelets ≥ 100,000/mm3 • Creatinine ≤ 1.5 mg/dL ( 133 mol/l) or creatinine clearance ≥ 60 mL/min • Serum bilirubin ≤ 2.0 mg/dL (≤ 35 umol/L) • SGOT/AST, SGPT/ALT and alkaline phosphatase ≤ 2 times ULN if liver metastases are absent by abdominal CT or MRI or ≤ 5 times ULN if liver metastases are present.
Description

Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C1254595
Subjects of child-bearing potential must be practicing adequate contraception (e.g. oral contraceptives, diaphragm plus spermicide, or IUD) for at least 3 months prior to study start. The same contraceptive method should be used throughout the study and continue for at least 4 weeks after the end of the study. Note: Women will be considered of childbearing potential if not surgically sterile or post-menopausal (i.e. documented absence of menses for one year prior to entry into the study).
Description

Childbearing Potential, Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria - Dose-Finding Run-In and Phase 2 Activity Assessment
Description

Exclusion Criteria - Dose-Finding Run-In and Phase 2 Activity Assessment

Alias
UMLS CUI-1
C0680251
Subject is pregnant or lactating.
Description

Pregnancy; Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Subject has received more than 1 prior chemotherapy regimen or a history of consolidation cytotoxic chemotherapy.
Description

Chemotherapy Regimen, Previous; Consolidation Chemotherapy, Cytotoxic Chemotherapy, Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C3179017
UMLS CUI [2,2]
C0677881
UMLS CUI [2,3]
C0262926
Subject has concomitant or history of previous malignancies, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for 5 years.
Description

Malignant Neoplasms, Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0262926
Subject has brain metastases as documented by CT or MRI. Note: Asymptomatic subjects do not require CT or MRI to rule out brain metastases.
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
Subject has received prior treatment with HYCAMTIN.
Description

Experimental drug, Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205156
Subject has received an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to study entry.
Description

Experimental drug, Other, Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0205156
Subject has received prior radiation therapy for ovarian cancer.
Description

Ovarian Carcinoma, Therapeutic radiology procedure, Before

Data type

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0332152
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Lab ID
Description

Laboratory Identifier

Data type

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Description

Performing laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Address
Description

Performing Laboratory, Street Address

Data type

text

Alias
UMLS CUI [1,1]
C1882331
UMLS CUI [1,2]
C1301826
Date sample taken
Description

Laboratory Procedures, Hematology finding, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Haematology Test
Description

Laboratory Procedures, Hematology finding

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
Result
Description

Laboratory Procedures, Hematology finding, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1274040
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Lab ID
Description

Laboratory Identifier

Data type

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Description

Performing laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Address
Description

Performing Laboratory, Street Address

Data type

text

Alias
UMLS CUI [1,1]
C1882331
UMLS CUI [1,2]
C1301826
Date sample taken
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Clinical Chemistry Test
Description

Laboratory Procedures, Chemistry, Clinical

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
Result
Description

Laboratory Procedures, Chemistry, Clinical, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1274040
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Similar models

Screen

1 forms
  1. StudyEvent: ODM
    1. Screen
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnic group
Code List
Ethnicity
CL Item
Hispanic or Latino  (1)
CL Item
Not Hispanic or Latino (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
African American/African Heritage  (1)
CL Item
American Indian or Alaskan Native  (2)
CL Item
Asian - Central/South Asian Heritage  (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage  (6)
CL Item
Native Hawaiian or Other Pacific Islander  (7)
CL Item
White - Arabic/North African Heritage  (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure - Diastolic
integer
C0871470 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Residual Toxicities Related to Previous Therapy for Ovarian Cancer
C0029925 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0013221 (UMLS CUI-3)
Ovarian Carcinoma, Prior Therapy, Drug toxicity
Item
Does the subject have any residual toxicities related to previous therapy for ovarian cancer?
boolean
C0029925 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
Ovarian Carcinoma, Prior Therapy, Drug toxicity, Diagnosis
Item
Diagnosis Only in the absence of a diagnosis, record the signs and symptoms on separate lines
text
C0029925 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,4])
Ovarian Carcinoma, Prior Therapy, Drug toxicity, Toxicity Grade
Item
NCI CTCAE v.3 Toxicity Grade
text
C0029925 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
C2826262 (UMLS CUI [1,4])
Item Group
Cancer Related Current Medical Conditions
Current Medical Status, Due to, Malignant Neoplasms
Item
Does the subject have any cancer related current medical conditions?
boolean
C3899485 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Current Medical Status, Due to, Malignant Neoplasms, Diagnosis
Item
Diagnosis Only in the absence of a diagnosis, record the signs and symptoms on separate lines
text
C3899485 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,4])
Current Medical Status, Due to, Malignant Neoplasms, Toxicity Grade
Item
NCI CTCAE v.3 Toxicity Grade
text
C3899485 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2826262 (UMLS CUI [1,4])
Item Group
Non-Cancer Related Current Medical Conditions
C0012634 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
Disease, Current
Item
Does the subject have any non-cancer related current medical conditions?
boolean
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Disease, Current, Diagnosis
Item
Diagnosis Only in the absence of a diagnosis, record the signs and symptoms on separate lines
text
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Disease, Current, Toxicity Grade
Item
NCI CTCAE v.3 Toxicity Grade
text
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,3])
Item Group
Disease Characteristics
C0029925 (UMLS CUI-1)
C0599878 (UMLS CUI-2)
Item
Primary Tumour Type at Initial Diagnosis
text
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
Primary Tumor, Type, at initial diagnosis
Code List
Primary Tumour Type at Initial Diagnosis
CL Item
Fallopian Tube (1)
CL Item
Ovary  (2)
CL Item
Primary Peritoneal (3)
Primary Tumor, Date of diagnosis
Item
Date of Initial Diagnosis
date
C0677930 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item
Stage at Initial Diagnosis
text
C0677930 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
Primary Tumor, Tumor Stage, at initial diagnosis
Code List
Stage at Initial Diagnosis
CL Item
Ia  (1)
CL Item
Ib  (2)
CL Item
Ic  (3)
CL Item
IIa  (4)
CL Item
IIb (5)
CL Item
IIc  (6)
CL Item
IIIa  (7)
CL Item
IIIb (8)
CL Item
IIIc  (9)
CL Item
IV (10)
Item
Histology at Initial Diagnosis
text
C0677930 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
Primary Tumor, Tumor Stage, at initial diagnosis
Code List
Histology at Initial Diagnosis
CL Item
Malignant serous tumours (1)
CL Item
Malignant mucinous tumours (2)
CL Item
Malignant endometrioid tumours (3)
CL Item
Clear cell (4)
CL Item
Mixed epithelial cell (5)
CL Item
Undifferentiated adenocarcinoma (6)
CL Item
Other, specify (7)
Item
Histological Grade at Initial Diagnosis
text
C0677930 (UMLS CUI [1,1])
C0919553 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
Primary Tumor, Tumor Stage, at initial diagnosis
Code List
Histological Grade at Initial Diagnosis
CL Item
Grade cannot be assessed (1)
CL Item
Well differentiated (2)
CL Item
Moderately differentiated  (3)
CL Item
Poorly differentiated (4)
CL Item
Undifferentiated (5)
Primary Tumor, End Date
Item
Date of Last Recurrence
date
C0677930 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Local Laboratory (Previous CA-125 Values - Including First-Line Treatment to Present) - Multiple Assessments
C0022885 (UMLS CUI-1)
C0006610 (UMLS CUI-2)
Performing laboratory name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Performing laboratory, Street Address
Item
Address
text
C1882331 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
Laboratory Identifier
Item
Lab ID
text
C2986056 (UMLS CUI [1])
Laboratory Procedures, CA-125 Antigen, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0006610 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, CA-125 Antigen, Result
Item
CA-125
text
C0022885 (UMLS CUI [1,1])
C0006610 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Prior Cancer Related Surgical Procedures
C0543467 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
C2826292 (UMLS CUI-3)
Operative Surgical Procedure, Previous, Related to Cancer
Item
Has the subject had prior surgery for the cancer under study?
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2826292 (UMLS CUI [1,3])
Operative Surgical Procedure, Previous, Related to Cancer
Item
Specific Procedure Record only one per line for each specific procedure
text
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2826292 (UMLS CUI [1,3])
Operative Surgical Procedure, Previous, Related to Cancer, Date in time
Item
Date of Procedure
date
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2826292 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biologic Therapy
C0920425 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
Cancer Treatment, Previous, Chemotherapy; Cancer Treatment, Previous, Hormone Therapy; Cancer Treatment, Previous, Immunotherapy; Cancer Treatment, Previous, Biological treatment
Item
Has the subject received prior chemotherapy, hormonal, immunotherapy, and/or biologic therapy for the cancer under study?
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0279025 (UMLS CUI [2,3])
C0920425 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0021083 (UMLS CUI [3,3])
C0920425 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1531518 (UMLS CUI [4,3])
Cancer Treatment, Previous, Medication name
Item
Drug Name
text
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Cancer Treatment, Previous, Chemotherapy Regimen, Sequence Number
Item
Regimen Sequence
text
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Item
Therapy Type
text
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Cancer Treatment, Previous, Type
Code List
Therapy Type
CL Item
Chemotherapy (1)
CL Item
Hormonal  (2)
CL Item
Immunotherapy (3)
CL Item
Biologic Therapy (4)
Cancer Treatment, Previous, Cycles, Numbers
Item
Drug Administration Specifics - Number of Cycles/ Doses
integer
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Cancer Treatment, Previous, Unit of Measure
Item
Drug Administration Specifics - Units
text
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Cancer Treatment, Previous, Dosage, Scheduled
Item
Drug Administration Specifics - Scheduled Dose
text
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
Cancer Treatment, Previous, Dosage, Unit of Measure
Item
Drug Administration Specifics - Dose Units
text
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Item
Intent
text
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Cancer Treatment, Previous, Reason
Code List
Intent
CL Item
Neo-adjuvant  (1)
CL Item
Adjuvant  (2)
CL Item
Advanced or Metastatic  (3)
CL Item
Local/Regional  (4)
CL Item
Prophylactic  (5)
CL Item
Radiosensitizer  (6)
CL Item
Not Applicable (7)
Cancer Treatment, Previous, Start Date
Item
Start Date
date
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Cancer Treatment, Previous, End Date
Item
Stop Date
date
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Best Response
text
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2986560 (UMLS CUI [1,3])
Cancer Treatment, Previous, Best Overall Response
Code List
Best Response
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Unknown  (5)
CL Item
Not Applicable (6)
Item
Duration of Response
integer
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0237585 (UMLS CUI [1,3])
Cancer Treatment, Previous, Best Overall Response
Code List
Duration of Response
Item Group
Lesion Assessment Using WHO Criteria - Indicator Lesions
C0221198 (UMLS CUI-1)
C1522602 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Lesion, Indicator, Numbers
Item
Lesion No.
integer
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Lesion, Indicator, Organ, Code
Item
Anatomic Description - Organ Code
text
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Lesion, Indicator, Location
Item
Anatomic Description - Lesion Location
text
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
Lesion, Indicator, Date in time
Item
Date
date
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Lesion, Indicator, Measurement method
Item
Can lesion be measured?
boolean
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
Lesion, Indicator, Diameter
Item
Diameter
integer
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Lesion, Indicator, Lesion size
Item
Product
integer
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0449453 (UMLS CUI [1,3])
Lesion, Indicator, Measurement method
Item
Method
text
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
Lesion, Indicator, Therapeutic radiology procedure, Previous
Item
Previously Irradiated
boolean
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
Item Group
Lesion Assessment Using WHO Criteria - Non-Measurable, Non-Evaluable Lesions
C1334988 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Non-Measurable Lesion, Numbers
Item
Lesion No.
integer
C1334988 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Measurable Lesion, Location
Item
Anatomic Description - Lesion Location
text
C1334988 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Non-Measurable Lesion, Date in time
Item
Date
date
C1334988 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Non-Measurable Lesion, Present
Item
Present
text
C1334988 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Non-Measurable Lesion, Absent
Item
Absent
text
C1334988 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Non-Measurable Lesion, Not Done
Item
Not Done
text
C1334988 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Regimen
C0087111 (UMLS CUI-1)
C1276413 (UMLS CUI-2)
Item
Check one
text
C0087111 (UMLS CUI [1,1])
C1276413 (UMLS CUI [1,2])
Therapeutic procedure, Therapeutic regimen
Code List
Check one
CL Item
Dose-Finding Run-In (1)
CL Item
Recommended Phase 2 Dose (2)
Item Group
Eligibility Question - Dose-Finding Run-In
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria for the dose-finding run-in phase?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria - Dose-Finding Run-In
C1512693 (UMLS CUI-1)
Epithelial ovarian cancer; Fallopian Tube Carcinoma; Primary peritoneal carcinoma
Item
Subject has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer which was histologically confirmed at the time of the primary diagnosis.
boolean
C0677886 (UMLS CUI [1,1])
C0238122 (UMLS CUI [1,2])
C1514428 (UMLS CUI [1,3])
Gender; Age; ECOG performance status
Item
Subject is female ≥ 18 years of age with an ECOG Performance Status of 0, 1 or 2.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C1520224 (UMLS CUI [1,3])
Chemotherapy Regimen, Platinum-based
Item
Subject has received one prior platinum-based chemotherapeutic regimen (containing either carboplatin or cisplatin) for the treatment of primary disease. Consolidation chemotherapy is not permitted.
boolean
C0392920 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
Platinum, Hypersensitivity; Platinum, Restistance
Item
Subject has potentially platinum-sensitive or platinum resistant disease.
boolean
C0032207 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0032207 (UMLS CUI [2,1])
C1522618 (UMLS CUI [2,2])
Non-cytotoxic Chemotherapy
Item
Subject is allowed to have received, but is not required to have received, one additional prior non- cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction.
boolean
C3898131 (UMLS CUI [1])
Measurable Disease
Item
Subject has measurable or evaluable disease (CA-125 positive, > 40 units/dL, on two separate tests at least a week apart).
boolean
C1513041 (UMLS CUI [1])
Laboratory Results
Item
Subject must have baseline laboratory values as follows: • Hemoglobin ≥ 9.0 g/dL • Neutrophils ≥ 1,500/mm3 • Platelets ≥ 100,000/mm3 • Creatinine ≤ 1.5 mg/dL (< 133 umol/l) or creatinine clearance ≥ 60 mL/min • Serum bilirubin ≤ 2.0 mg/dL (≤ 35 umol/L) • SGOT/AST, SGPT/ALT and alkaline phosphatase ≤ 2 times ULN if liver metastases are absent by abdominal CT or MRI or ≤ 5 times ULN if liver metastases are present.
boolean
C1254595 (UMLS CUI [1])
Childbearing Potential, Contraceptive methods
Item
Subjects of child-bearing potential must be practicing adequate contraception (e.g. oral contraceptives, diaphragm plus spermicide, or IUD) for at least 3 months prior to study start. The same contraceptive method should be used throughout the study and continue for at least 4 weeks after the end of the study. Note: Women will be considered of childbearing potential if not surgically sterile or post-menopausal (i.e. documented absence of menses for one year prior to entry into the study).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
Eligibility Question - Phase 2 Activity Assessment
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria for the phase 2 activity?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria - Phase 2 Activity Assessment
C1512693 (UMLS CUI-1)
Epithelial ovarian cancer; Fallopian Tube Carcinoma; Primary peritoneal carcinoma
Item
Subject has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer which was histologically confirmed at the time of the primary diagnosis.
boolean
C0677886 (UMLS CUI [1,1])
C0238122 (UMLS CUI [1,2])
C1514428 (UMLS CUI [1,3])
Gender; Age; ECOG performance status
Item
Subject is female ≥ 18 years of age with an ECOG Performance Status of 0, 1 or 2.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C1520224 (UMLS CUI [1,3])
Chemotherapy Regimen, Platinum-based
Item
Subject has received one prior platinum-based chemotherapeutic regimen (containing either carboplatin or cisplatin) for the treatment of primary disease. Consolidation chemotherapy is not permitted.
boolean
C0392920 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
Disease, Platinum, Sensitive
Item
Subject’s disease is considered potentially platinum-sensitive (i.e., have had a platinum-free interval following complete response to carboplatin or cisplatin of greater than 6 months).
boolean
C0012634 (UMLS CUI [1,1])
C0032207 (UMLS CUI [1,2])
C0332324 (UMLS CUI [1,3])
Non-cytotoxic Chemotherapy
Item
Subject is allowed to have received, but is not required to have received, one additional prior non- cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction.
boolean
C3898131 (UMLS CUI [1])
Measurable Disease
Item
Subject must have at least one measurable lesion as determined by diagnostic studies including CT or MRI or physical exam. • Measurable disease on CT or MRI must have one diameter ≥ 1 cm and one diameter ≥ 2 cm, • Palpable tumor masses that cannot be evaluated radiologically must have 2 diameters ≥ 2 cm. An attempt to document lesion size by ultrasound should be undertaken for palpable lesions not visualized on CT (or MRI). The same diagnostic imaging method used to evaluate disease must be used throughout the study to evaluate lesions consistently.
boolean
C1513041 (UMLS CUI [1])
Laboratory Results
Item
Subject must have baseline laboratory values as follows: • Hemoglobin ≥ 9.0 g/dL • Neutrophils ≥ 1,500/mm3 • Platelets ≥ 100,000/mm3 • Creatinine ≤ 1.5 mg/dL ( 133 mol/l) or creatinine clearance ≥ 60 mL/min • Serum bilirubin ≤ 2.0 mg/dL (≤ 35 umol/L) • SGOT/AST, SGPT/ALT and alkaline phosphatase ≤ 2 times ULN if liver metastases are absent by abdominal CT or MRI or ≤ 5 times ULN if liver metastases are present.
boolean
C1254595 (UMLS CUI [1])
Childbearing Potential, Contraceptive methods
Item
Subjects of child-bearing potential must be practicing adequate contraception (e.g. oral contraceptives, diaphragm plus spermicide, or IUD) for at least 3 months prior to study start. The same contraceptive method should be used throughout the study and continue for at least 4 weeks after the end of the study. Note: Women will be considered of childbearing potential if not surgically sterile or post-menopausal (i.e. documented absence of menses for one year prior to entry into the study).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
Exclusion Criteria - Dose-Finding Run-In and Phase 2 Activity Assessment
C0680251 (UMLS CUI-1)
Pregnancy; Breast Feeding
Item
Subject is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy Regimen, Previous; Consolidation Chemotherapy, Cytotoxic Chemotherapy, Medical History
Item
Subject has received more than 1 prior chemotherapy regimen or a history of consolidation cytotoxic chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3179017 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
Malignant Neoplasms, Medical History
Item
Subject has concomitant or history of previous malignancies, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for 5 years.
boolean
C0006826 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
Subject has brain metastases as documented by CT or MRI. Note: Asymptomatic subjects do not require CT or MRI to rule out brain metastases.
boolean
C0220650 (UMLS CUI [1])
Experimental drug, Previous
Item
Subject has received prior treatment with HYCAMTIN.
boolean
C0304229 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Experimental drug, Other, Previous
Item
Subject has received an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to study entry.
boolean
C0304229 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Ovarian Carcinoma, Therapeutic radiology procedure, Before
Item
Subject has received prior radiation therapy for ovarian cancer.
boolean
C0029925 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory Identifier
Item
Lab ID
text
C2986056 (UMLS CUI [1])
Performing laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Performing Laboratory, Street Address
Item
Address
text
C1882331 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Haematology Test
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding
Code List
Haematology Test
CL Item
Haemoglobin (1)
CL Item
Haematocrit (2)
CL Item
Red Blood Cell (3)
CL Item
White Blood Cell (4)
CL Item
Platelet (5)
CL Item
Neutrophils (6)
CL Item
Bands (7)
CL Item
Lymphocytes (8)
CL Item
Monocytes (9)
CL Item
Eosinophils (10)
CL Item
Basophils (11)
Laboratory Procedures, Hematology finding, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Laboratory Identifier
Item
Lab ID
text
C2986056 (UMLS CUI [1])
Performing laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Performing Laboratory, Street Address
Item
Address
text
C1882331 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date sample taken
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Clinical Chemistry Test
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Laboratory Procedures, Chemistry, Clinical
Code List
Clinical Chemistry Test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Calcium (5)
CL Item
Phosphorus (6)
CL Item
Magnesium (7)
CL Item
Blood Urea Nitrogen (BUN) (8)
CL Item
Urea (9)
CL Item
Uric acid (10)
CL Item
Creatinine (11)
CL Item
LDH (12)
CL Item
Aspartate Aminotransferase (AST) (13)
CL Item
Alanine Transaminase (ALT) (14)
CL Item
Bilirubin (total) (15)
CL Item
Protein (total) (16)
CL Item
Albumin (17)
CL Item
Creatinine Clearance (calculated) (18)
CL Item
CA125 (19)
Laboratory Procedures, Chemistry, Clinical, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
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