A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer
Data Collection
Carcinoma, Ovarian Epithelial+18
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.This study focuses on treating advanced ovarian cancer, including ovarian epithelial, primary peritoneal, or fallopian tube cancer that is recurrent, persistent, or progressive. The main goal is to evaluate the effectiveness of a combination therapy using two drugs, UCN-01 and topotecan, in shrinking or halting the growth of cancer. The study aims to help improve treatment options for this condition, addressing the need for more effective therapies. During the study, participants receive UCN-01 through an IV over 3 hours on day 1, followed by topotecan via IV over 30 minutes on days 1 through 5. This cycle repeats every 21 days for up to 6 courses, unless there is disease progression or intolerable side effects. The study measures the safety and effectiveness of this treatment regimen, looking at factors like response rates, disease stability, survival rates, and any side effects. The plan is to enroll 19 to 33 patients over a period of 5 to 11 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Margaret and Charles Juravinski Cancer Centre
Hamilton, CanadaOpen Margaret and Charles Juravinski Cancer Centre in Google MapsCancer Care Ontario-London Regional Cancer Centre
London, CanadaOttawa Regional Cancer Centre
Ottawa, CanadaPrincess Margaret Hospital
Toronto, Canada