A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer

Date de début de l'étude : 1 janvier 2004

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer * Progressive, persistent, or recurrent disease * Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy * Tumor lesions accessible for biopsy * Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator * No more than 2 prior chemotherapy regimens * At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin) * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 12 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN Renal * Creatinine no greater than ULN OR * Creatinine clearance at least 50 mL/min Cardiovascular * No history of coronary artery disease * No symptomatic cardiac dysfunction * No cardiac pathology by electrocardiogram\* NOTE: \*Patients with symptomatic coronary artery disease must undergo an electrocardiogram Pulmonary * No symptomatic pulmonary dysfunction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 8 weeks after study participation * No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents * No insulin-dependent diabetes mellitus * Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator * No other concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior biologic therapy and recovered Chemotherapy * See Disease Characterisitcs * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No prior topotecan * No other prior topoisomerase I inhibitors Endocrine therapy * More than 4 weeks since prior hormonal therapy and recovered Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 40% of bone marrow * No prior mediastinal irradiation Surgery * More than 4 weeks since prior surgery and recovered Other * No other concurrent anticancer therapy * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients