A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin

Date de début de l'étude : 1 janvier 1995

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.