Ovarian Cancer, Primary Peritoneal Cavity Cancer
Conditions
Keywords
stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
Detailed description
OBJECTIVES: * Determine the antitumor activity of nitrocamptothecin in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer. * Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: Patients receive oral nitrocamptothecin on days 1-5. Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 weeks, then every 3 months for 2 years, and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 22 months.
Interventions
DRUGrubitecan
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer * Measurable disease * Ascites and pleural effusions are not considered measurable * Sonography allowed if bidimensionally measurable * Must not be eligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and alkaline phosphatase no greater than 3 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Other: * No other prior or concurrent invasive malignancy in the past 5 years except nonmelanoma skin cancer * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least but no more than 2 prior chemotherapy regimens containing carboplatin, cisplatin, or another organoplatinum compound combined with paclitaxel * Second line therapy may include any agents except topoisomerase I inhibitors (i.e., topotecan) * No prior nitrocamptothecin or topoisomerase I inhibitors * At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Surgery: * At least 3 weeks since prior surgery and recovered Other: * No prior cancer therapy that contraindicates this study
Outcome results
None listed