Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT00003733
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial carcinoma with greater than 1 cm residual disease at completion of initial surgery Stage IIB, IIIA, IIIB, IIIC, or IV Measurable disease OR CA 125 greater than 120 units/mL obtained post surgery
PATIENT CHARACTERISTICS: See General Eligibility Criteria
PRIOR CONCURRENT THERAPY: Biological therapy: No prior or concurrent immunotherapy Chemotherapy: No prior or concurrent chemotherapy Endocrine: No prior or concurrent hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy except to limited fields (e.g., for palliation of bone pain) Surgery: Diagnostic surgery performed less than 12 weeks prior to study No concurrent interval debulking Other: At least 30 days or five half-lives since any prior investigational therapy No other concurrent investigational therapy --Patients Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 4,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 5 times ULN if liver and/or bone metastases present) Renal: Creatine less than 2 times ULN Creatinine clearance at least 50 mL/min Other: No prior malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix No uncontrolled infection No other concurrent medical conditions that would prevent full compliance or expose patient to extreme risk or decreased life expectancy No concurrent medical condition for which treament with platinum compounds is contraindicated No history of allergy to compounds related to the drugs used in this study No prior motor or sensory neurotoxicity grade 2 or worse Not pregnant or nursing Fertile patients must use effective contraception
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00003733
Study Brief:
Protocol Section:
NCT00003733