combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary 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 combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer.

objectives: * determine the maximum tolerated doses of the combination of gemcitabine and topotecan administered with and without filgrastim (g-csf) in patients with refractory ovarian or fallopian tube cancer. * describe and quantitate the clinical toxicities of these regimens in this patient population. outline: this is a dose escalation study. patients receive gemcitabine iv over 30 minutes on days 1 and 8 and topotecan iv over 30 minutes on days 2-4. some patients receive filgrastim (g-csf) subcutaneously on days 9-14. treatment repeats every 28 days for up to 5-10 courses. cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity (dlt). dose escalation of gemcitabine then continues in cohorts of 3-6 patients until the mtd is determined. the mtd is defined as the dose below that at which 2 of 6 patients experience dlt. patients are followed every 2-3 months for 2 years, every 6 months for 3 years, then annually thereafter. projected accrual: approximately 24 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer * no borderline ovarian cancer * extra-ovarian papillary serous tumors eligible * must not be eligible for any higher priority phase ii or iii gog protocol patient characteristics: age: * 18 and over performance status: * gog 0-2 life expectancy: * not specified hematopoietic: * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * sgot no greater than 3 times upper limit of normal (uln) * bilirubin no greater than 1.5 mg/dl * elevated levels of alkaline phosphatase allowed renal: * creatinine no greater than 1.5 mg/dl cardiovascular: * no angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias * no uncontrolled hypertension other: * no other active malignancy * no prior malignancy within the past 5 years except nonmelanomatous skin cancer * no active infection * no underlying medical problem that would prevent compliance * no known hypersensitivity to e. coli-derived drug preparations * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * must have received at least 1 prior platinum- and paclitaxel-based regimen * at least 4 weeks since prior chemotherapy * no prior topotecan and/or gemcitabine * no prior chemotherapy for a different prior malignancy endocrine therapy: * not specified radiotherapy: * no prior radiotherapy to more than 10% of bone marrow * at least 2 weeks since limited field radiation therapy surgery: * not specified

Keywords: stage i ovarian epithelial cancer stage ii ovarian epithelial cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer