Informações:
Falhas:
ID
37253
Descrição
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
Palavras-chave
Versões (1)
- 12/07/2019 12/07/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
12 de julho de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173
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- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
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)
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)
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])
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])
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])
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])
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])
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])
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)
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])
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])
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])
C0521116 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,3])
Item Group
Disease Characteristics
C0029925 (UMLS CUI-1)
C0599878 (UMLS CUI-2)
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])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
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])
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])
C1300072 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
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])
C0019638 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
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])
C0919553 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
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])
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)
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])
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])
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])
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)
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])
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])
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])
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)
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])
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])
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])
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])
C0205156 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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])
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])
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])
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])
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])
C0205156 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
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])
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])
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])
C0205156 (UMLS CUI [1,2])
C2986560 (UMLS CUI [1,3])
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])
C0205156 (UMLS CUI [1,2])
C0237585 (UMLS CUI [1,3])
Item Group
Lesion Assessment Using WHO Criteria - Indicator Lesions
C0221198 (UMLS CUI-1)
C1522602 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
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])
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])
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])
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])
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])
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])
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])
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])
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])
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)
C0220825 (UMLS CUI-2)
Non-Measurable Lesion, Numbers
Item
Lesion No.
integer
C1334988 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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])
C0450429 (UMLS CUI [1,2])
Non-Measurable Lesion, Date in time
Item
Date
date
C1334988 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Non-Measurable Lesion, Present
Item
Present
text
C1334988 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
Non-Measurable Lesion, Absent
Item
Absent
text
C1334988 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Non-Measurable Lesion, Not Done
Item
Not Done
text
C1334988 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
Item Group
Regimen
C0087111 (UMLS CUI-1)
C1276413 (UMLS CUI-2)
C1276413 (UMLS CUI-2)
Item
Check one
text
C0087111 (UMLS CUI [1,1])
C1276413 (UMLS CUI [1,2])
C1276413 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C1522449 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
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])
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])
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])
C0474523 (UMLS CUI [1,2])
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])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
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])
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])
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])
C0008000 (UMLS CUI [1,2])
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])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])