nitrocamptothecin in treating patients with advanced ovarian cancer

Conditions: Ovarian Cancer

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.

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.

Eligibility 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

Keywords: stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer recurrent ovarian epithelial cancer