A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors

Date de début de l'étude : 1 juin 2002

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer * Measurable disease outside of field of prior radiotherapy OR * Progressive disease within field after radiotherapy * Must have had no more than 2 prior chemotherapy regimens * At least 1 prior regimen must have included a platinum agent (e.g., 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 coronary artery disease * No symptomatic cardiac dysfunction * No symptoms suggestive of coronary artery disease with evidence of cardiac pathology Pulmonary * No symptomatic pulmonary dysfunction Other * No prior allergic reaction attributed to compounds of similar chemical or biologic composition to UCN-01 or other agents used in this study * No insulin-dependent diabetes mellitus * No other uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior biologic therapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior topotecan (other prior topoisomerase I inhibitors allowed) Endocrine therapy * At least 4 weeks since prior hormonal therapy Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No prior radiotherapy to more than 40% of bone marrow * No prior mediastinal irradiation Surgery * At least 4 weeks since prior surgery Other * Recovered from all prior therapy * No other concurrent investigational agents * No other concurrent anticancer agents or therapies * No concurrent combination antiretroviral therapy for HIV-positive patients