Ovarian Cancer
Conditions
Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial 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 advanced ovarian cancer.
Detailed description
OBJECTIVES: * Determine the objective response rate and duration of response in patients with advanced ovarian cancer treated with nitrocamptothecin. * Determine the probability of objective response as expressed by the response rate in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory). Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past PR or CR. Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy. PROJECTED ACCRUAL: A total of 28-50 patients (14-25 per stratum) will be accrued for this study.
Interventions
DRUGrubitecan
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven metastatic or unresectable locally advanced progressive ovarian cancer that has failed first line platinum and taxane based regimen * Refractory disease defined by a relapse within 1 year after completion of first line therapy * Sensitive disease defined by a relapse greater than 1 year after completion of first line therapy * Minimum of 1 target lesion that can be accurately measured in at least 1 dimension * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 times ULN (no greater than 5 times ULN if hepatic metastases present) Renal: * Creatinine no greater than 1.7 mg/dL Cardiovascular: * No ischemic heart disease within the past 6 months * Normal 12 lead electrocardiogram Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No unstable systemic disease or active uncontrolled infections * No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma of the cervix * No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) with nitrocamptothecin Chemotherapy: * See Disease Characteristics * Greater than 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Greater than 4 weeks since prior radiotherapy Surgery: * Greater than 2 weeks since prior major surgery Other: * No other concurrent anticancer agents * No other concurrent investigational therapy
Countries
Belgium, France, Israel, Italy, Spain, Switzerland, United Kingdom
Outcome results
None listed