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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Women's Cancer Center
Palo Alto, California, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
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Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States