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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00001427
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Histologically proven, advanced epithelial ovarian cancer.
Histologic confirmation by Pathology Department, NIH, required.
Recurrent disease after paclitaxel and either cisplatin or carboplatin. Combination platinum/paclitaxel acceptable.
Bidimensionally measurable disease on physical exam, radiographs, or peritoneoscopy. Repeat peritoneoscopy after 8 courses of therapy required if documentation of disease was solely by peritoneoscopy.
Laparotomy not required.
No CNS metastasis.
No borderline or mixed histology.
PRIOR/CONCURRENT THERAPY:
See Disease Characteristics.
More than 4 weeks since any prior therapy and recovered.
No prior camptothecin analogue-based chemotherapy.
No prior radiotherapy except intraperitoneal 32-P.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2.
Hematopoietic:
WBC greater than 3,000.
AGC greater than 1,500.
Platelets at least 100,000.
Hemoglobin greater than 9 g/dL OR;
Hematocrit greater than 27 g/dL.
Hepatic:
Bilirubin no greater than 1.5 mg/dL.
Serum transaminases no greater than 2 times normal.
Renal:
24-hour creatinine clearance greater than 45 mL/min (documented by NCI investigator or primary care physician).
Cardiovascular:
No myocardial infarction within 12 months.
No active congestive heart failure.
No heart block.
No arrhythmia requiring medication.
OTHER:
No active uncontrolled infection.
No known HIV positivity.
No second malignancy currently under treatment except: Local basal cell carcinoma of the skin, Cervical carcinoma in situ, Other malignancies (e.g., stage I breast cancer) eligible at the discretion of the principal or associate investigators.
No pregnant women.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00001427
Study Brief:
Protocol Section:
NCT00001427