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:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT00003892
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically documented ovarian epithelial cancer Metastatic and/or locally recurrent disease that is incurable with standard therapy Must have received 1 or 2 prior regimens of chemotherapy At least 1 regimen must have contained cisplatin or carboplatin Bidimensionally measurable disease Indicator lesion size must be as follows: At least 4-50 cm2 by CT scan At least 1 cm2 by chest xray At least 1 cm2 (e.g., nodules) by physical exam No abdominal adenocarcinoma of unknown origin No borderline ovarian tumor No tumor known to be of primary fallopian tube or peritoneal origin
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 No known bleeding disorder Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST less than 5 times ULN PT/PTT normal (except when elevated due to therapeutic coumadin) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No significant cardiac dysfunction Neurologic No history of significant neurologic disorder No significant psychiatric disorder Other: Not pregnant or nursing Fertile patients must use effective contraception At least 5 years since prior malignancy and no evidence of recurrence No other serious illness or medical condition No active uncontrolled infection No complete bowel obstruction
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy At least 4 weeks since radiotherapy to at least 20% of bone marrow Surgery: Not specified Other: As least 28 days since prior investigational agent or new anticancer therapy No concurrent therapeutic heparin No other concurrent investigational therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00003892
Study Brief:
Protocol Section:
NCT00003892