UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer, stage III ovarian epithelial cancer
Eligibility Criteria
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
Sites / Locations
- Margaret and Charles Juravinski Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre
- Princess Margaret Hospital