oxaliplatin and topotecan in treating patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer.

objectives: * determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and topotecan in patients with previously treated ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. * determine the qualitative and quantitative toxic effects of this regimen in these patients. * determine the pharmacokinetics of this regimen in these patients. * determine the antitumor activity of this treatment regimen in these patients. * determine the correlation between the pharmacokinetic and safety data of this regimen in these patients. outline: this is a dose-escalation, multicenter study. patients receive oxaliplatin iv over 2 hours on days 1 and 15 and topotecan iv continuously on days 1-15. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator. cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. patients are followed through day 30. projected accrual: a minimum of 15 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer * prior chemotherapy required * measurable or evaluable disease * no symptomatic, untreated brain metastases patient characteristics: age: * 18 and over performance status: * karnofsky 70-100% life expectancy: * at least 4 months hematopoietic: * wbc greater than 3,000/mm\^3 * absolute neutrophil count greater than 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) or * sgot no greater than 2.5 times uln (5 times uln if liver metastases) renal: * creatinine no greater than 1.5 times uln or * creatinine clearance at least 50 ml/min cardiovascular: * no uncontrolled symptomatic congestive heart failure * no unstable angina pectoris * no uncontrolled cardiac arrhythmia other: * no other active cancer * no prior allergy to platinum compounds * no prior allergic reactions to appropriate antiemetics (e.g., serotonin or antagonists) administered concurrently with study * no other uncontrolled concurrent illness (e.g., infection) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study therapy prior concurrent therapy: biologic therapy: * see chemotherapy * no concurrent colony stimulating factors during topotecan administration chemotherapy: * see disease characteristics * no prior high-dose chemotherapy requiring bone marrow or peripheral blood stem cell transplantation * at least 4 weeks since prior chemotherapy and recovered endocrine therapy: * not specified radiotherapy: * no prior radiotherapy to whole pelvic field * at least 2 weeks since prior radiotherapy and recovered surgery: * no unresolved sequelae resulting from prior surgery other: * at least 4 weeks since other prior investigational drug * no other concurrent investigational agents * no other concurrent anticancer therapy

Keywords: recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer