ID

37735

Description

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Keywords

Versions (1)
  1. 8/20/19 8/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 20, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. Females at least 18 years of age.
Description

Females at least 18 years of age.

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
3. Histologically diagnosed disease consistent with epithelial ovarian carcinoma that is now recurrent (Inclusion Criterion #6). In addition, fallopian tube, primary peritoneal, and mixed mullerian tumors will also be aIlowed.
Description

Histologic; Diagnosis | Epithelial ovarian cancer | Fallopian Tube Carcinoma | Primary peritoneal carcinoma | Mixed Tumor, Mullerian

Data type

boolean

Alias
UMLS CUI [1,1]
C0205462
UMLS CUI [1,2]
C0011900
UMLS CUI [2]
C0677886
UMLS CUI [3]
C0238122
UMLS CUI [4]
C1514428
UMLS CUI [5]
C0206627
4. Patients who had one prior platinum—based chemotherapeutic regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for the treatment of primary disease.
Description

Prior Chemotherapy | Chemotherapy Regimen; Platinum-Based | Carboplatin | Cisplatin | primary disorders

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1514162
UMLS CUI [3]
C0079083
UMLS CUI [4]
C0008838
UMLS CUI [5]
C0277554
5. Presence of at least one bidimensionally measurable lesion as determined by diagnostic studies including CT or MRI.
Description

- Measurable disease on CT or MRI scan must have one diameter >= 1 cm and one diameter >= 2 cm. - Palpable tumor masses that cannot be evaluated radiologically must have two diameters >= 2 cm. Any tumor measurement relying solely on physical examination should be verified by a second physician. The same diagnostic imaging method must be used throughout the study to evaluate the lesions. Measurable lesions may not include brain metastases.

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1705052
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
6. Patients must be considered platinum-sensitive according to standard GOG criteria (i.e.,have had a treatment-free interval following response to platinum of greater than 6 months).
Description

Platinum; Sensitive | Gynecologic Oncology Group | Interval; Disease; Free of (attribute) | Response to treatment; Platinum

Data type

boolean

Alias
UMLS CUI [1,1]
C0032207
UMLS CUI [1,2]
C0332324
UMLS CUI [2]
C1512288
UMLS CUI [3,1]
C1272706
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [4,1]
C0521982
UMLS CUI [4,2]
C0032207
7. At least 4 weeks since last surgery or radiation therapy. The measurable Iesions may not be in the field of prior radiation.
Description

Operative Surgical Procedures | Therapeutic radiology procedure | Measurable Disease; Location

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0450429
8. ECOG performance status of 0, 1, or 2 and life expectancy >= 3 months.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
9. Laboratory values
Description

As follows: Hemoglobin >= 9.0 g/dL [ 90 g/L] WBC >= 3,500/mm3 [>=3.5 X10^9/L] Neutrophils >= 1,500/mm3 [>= 1.5 x 10^9/L] Platelets >= 100,000/mm3 [>= 100.0 x10^9/L] Serum creatinine <= 1.0 mg/dL [88.4 umol/L] or creatinine clearance >= 60 mL/min Serum bilirubin >=v2.0 mg/dL (<= 35 umol/L) SGOT/AST, SGPT/ALT, and alkaline phosphatase <= 2 times the upper limit of normal of liver metastases are absent by abdominal CT or MRI scan, or <= 5 times the upper limit of normal if liver metastases are present

Data type

boolean

Alias
UMLS CUI [1]
C0022885
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Women of child-bearing potential who are not practicing adequate contraception (e.g., oral contraceptives, diaphragm plus spermicide, or IUD) for at least three months before the start of the study.
Description

The same contraceptive method should be used throughout the study and continue for at least 4 weeks after the end of the study. A woman will be considered to be of childbearing potential if she is not surgically sterile or post—menopausal (i.e., documented absence of menses for one year prior to entry into the study).

Data type

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3,1]
C0042241
UMLS CUI [3,2]
C0037862
UMLS CUI [4]
C1706306
2. Patients who are pregnant or lactating.
Description

Pregnancy; Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
3. Histologic diagnosis of borderline, low-malignant potential grade (Grade 0) epithelial carcinoma.
Description

Histopathologic Grade | Borderline; Carcinoma; epithelial | Low Grade Malignant Neoplasm; Carcinoma; epithelial

Data type

boolean

Alias
UMLS CUI [1]
C0919553
UMLS CUI [2,1]
C0205189
UMLS CUI [2,2]
C0007097
UMLS CUI [2,3]
C0221908
UMLS CUI [3,1]
C1334425
UMLS CUI [3,2]
C0007097
UMLS CUI [3,3]
C0221908
4. Patients who received more than one prior chemotherapy regimen.
Description

Prior Chemotherapy; Chemotherapy Regimen; Numbers

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0237753
5. Other concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease—free for 5 years.
Description

Comorbidity; Malignant Neoplasms | Basal cell carcinoma; Treating; Adequate | Squamous cell carcinoma of skin; Treating; Adequate | Carcinoma in situ of uterine cervix | Incidental Findings; Carcinoid Tumor | Disease; Free of (attribute)

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
UMLS CUI [4]
C0851140
UMLS CUI [5,1]
C0743997
UMLS CUI [5,2]
C0007095
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0332296
6. Active uncontrolled infection requiring treatment with antibiotics.
Description

Communicable Diseases; Requirement; Antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0338237
7. Concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
Description

Comorbidity; Severe (severity modifier); Malignant Neoplasms; Unrelated (finding) | Compliance behavior | Risk; Extreme | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C0445356
UMLS CUI [2]
C1321605
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0205403
UMLS CUI [4]
C0023671
8. Patients who have received radiation to more than 10% of marrow-bearing areas.
Description

Therapeutic radiology procedure | Bone Marrow

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0005953
9. Patients for whom other concomitant chemotherapeutic agents, immunotherapy, hormonal therapy, radiation therapy, surgery, or anticancer treatment is planned.
Description

Concomitant Agent; Chemotherapeutic agent | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Operative Surgical Procedures | cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0729502
UMLS CUI [2]
C0021083
UMLS CUI [3]
C0279025
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0920425
10. Prior treatment with topotecan or gemcitabine.
Description

Prior Therapy | Topotecan | gemcitabine

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0146224
UMLS CUI [3]
C0045093
11. Hypersensitivity to camptothecin or nucleoside analogues, or chemically related compounds.
Description

Camptothecin; Hypersensitivity | Nucleoside Analogs; Hypersensitivity | Compound (substance); Relationships

Data type

boolean

Alias
UMLS CUI [1,1]
C0006812
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C1579410
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C1706082
UMLS CUI [3,2]
C0439849
12. Use of an investigational agent within 30 days or 5 half-lives (whichever is longer) preceding entry into this study.
Description

INVESTIGATIONAL AGENTS; Before; Clinical Trial Period

Data type

boolean

Alias
UMLS CUI [1,1]
C1875319
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Did the patient meet all inclusion and exclusion criteria?
Description

Did the patient meet all inclusion and exclusion criteria?

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
Did the patient meet all inclusion and exclusion criteria?
Description

Did the patient meet all inclusion and exclusion criteria?

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Written informed consent
Item
1. Written informed consent
boolean
C0021430 (UMLS CUI [1])
Females at least 18 years of age.
Item
2. Females at least 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Histologic; Diagnosis | Epithelial ovarian cancer | Fallopian Tube Carcinoma | Primary peritoneal carcinoma | Mixed Tumor, Mullerian
Item
3. Histologically diagnosed disease consistent with epithelial ovarian carcinoma that is now recurrent (Inclusion Criterion #6). In addition, fallopian tube, primary peritoneal, and mixed mullerian tumors will also be aIlowed.
boolean
C0205462 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0677886 (UMLS CUI [2])
C0238122 (UMLS CUI [3])
C1514428 (UMLS CUI [4])
C0206627 (UMLS CUI [5])
Prior Chemotherapy | Chemotherapy Regimen; Platinum-Based | Carboplatin | Cisplatin | primary disorders
Item
4. Patients who had one prior platinum—based chemotherapeutic regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for the treatment of primary disease.
boolean
C1514457 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0079083 (UMLS CUI [3])
C0008838 (UMLS CUI [4])
C0277554 (UMLS CUI [5])
Lesion; Measurable; 2-Dimensional | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
5. Presence of at least one bidimensionally measurable lesion as determined by diagnostic studies including CT or MRI.
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
Platinum; Sensitive | Gynecologic Oncology Group | Interval; Disease; Free of (attribute) | Response to treatment; Platinum
Item
6. Patients must be considered platinum-sensitive according to standard GOG criteria (i.e.,have had a treatment-free interval following response to platinum of greater than 6 months).
boolean
C0032207 (UMLS CUI [1,1])
C0332324 (UMLS CUI [1,2])
C1512288 (UMLS CUI [2])
C1272706 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0521982 (UMLS CUI [4,1])
C0032207 (UMLS CUI [4,2])
Operative Surgical Procedures | Therapeutic radiology procedure | Measurable Disease; Location
Item
7. At least 4 weeks since last surgery or radiation therapy. The measurable Iesions may not be in the field of prior radiation.
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1513041 (UMLS CUI [3,1])
C0450429 (UMLS CUI [3,2])
ECOG performance status
Item
8. ECOG performance status of 0, 1, or 2 and life expectancy >= 3 months.
boolean
C1520224 (UMLS CUI [1])
Laboratory values
Item
9. Laboratory values
boolean
C0022885 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Female of child bearing age; Contraceptive methods | Contraceptives, Oral | Vaginal contraceptive diaphragm (device); Spermatocidal Agents | Intrauterine Device Dosage Form
Item
1. Women of child-bearing potential who are not practicing adequate contraception (e.g., oral contraceptives, diaphragm plus spermicide, or IUD) for at least three months before the start of the study.
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0042241 (UMLS CUI [3,1])
C0037862 (UMLS CUI [3,2])
C1706306 (UMLS CUI [4])
Pregnancy; Breast Feeding
Item
2. Patients who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Histopathologic Grade | Borderline; Carcinoma; epithelial | Low Grade Malignant Neoplasm; Carcinoma; epithelial
Item
3. Histologic diagnosis of borderline, low-malignant potential grade (Grade 0) epithelial carcinoma.
boolean
C0919553 (UMLS CUI [1])
C0205189 (UMLS CUI [2,1])
C0007097 (UMLS CUI [2,2])
C0221908 (UMLS CUI [2,3])
C1334425 (UMLS CUI [3,1])
C0007097 (UMLS CUI [3,2])
C0221908 (UMLS CUI [3,3])
Prior Chemotherapy; Chemotherapy Regimen; Numbers
Item
4. Patients who received more than one prior chemotherapy regimen.
boolean
C1514457 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Comorbidity; Malignant Neoplasms | Basal cell carcinoma; Treating; Adequate | Squamous cell carcinoma of skin; Treating; Adequate | Carcinoma in situ of uterine cervix | Incidental Findings; Carcinoid Tumor | Disease; Free of (attribute)
Item
5. Other concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease—free for 5 years.
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4])
C0743997 (UMLS CUI [5,1])
C0007095 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
Communicable Diseases; Requirement; Antibiotic therapy
Item
6. Active uncontrolled infection requiring treatment with antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
Comorbidity; Severe (severity modifier); Malignant Neoplasms; Unrelated (finding) | Compliance behavior | Risk; Extreme | Life Expectancy
Item
7. Concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0445356 (UMLS CUI [1,4])
C1321605 (UMLS CUI [2])
C0035647 (UMLS CUI [3,1])
C0205403 (UMLS CUI [3,2])
C0023671 (UMLS CUI [4])
Therapeutic radiology procedure | Bone Marrow
Item
8. Patients who have received radiation to more than 10% of marrow-bearing areas.
boolean
C1522449 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
Concomitant Agent; Chemotherapeutic agent | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Operative Surgical Procedures | cancer treatment
Item
9. Patients for whom other concomitant chemotherapeutic agents, immunotherapy, hormonal therapy, radiation therapy, surgery, or anticancer treatment is planned.
boolean
C2347852 (UMLS CUI [1,1])
C0729502 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0920425 (UMLS CUI [6])
Prior Therapy | Topotecan | gemcitabine
Item
10. Prior treatment with topotecan or gemcitabine.
boolean
C1514463 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
C0045093 (UMLS CUI [3])
Camptothecin; Hypersensitivity | Nucleoside Analogs; Hypersensitivity | Compound (substance); Relationships
Item
11. Hypersensitivity to camptothecin or nucleoside analogues, or chemically related compounds.
boolean
C0006812 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1706082 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
INVESTIGATIONAL AGENTS; Before; Clinical Trial Period
Item
12. Use of an investigational agent within 30 days or 5 half-lives (whichever is longer) preceding entry into this study.
boolean
C1875319 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Item Group
Did the patient meet all inclusion and exclusion criteria?
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
Did the patient meet all inclusion and exclusion criteria?
Item
Did the patient meet all inclusion and exclusion criteria?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
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