Spots Global Cancer Trial Database for Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer

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Trial Identification

Brief Title: Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer

Official Title: A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube

Study ID: NCT00003382

Conditions

Fallopian Tube Cancer

Ovarian Cancer

Primary Peritoneal Cavity Cancer

Interventions

filgrastim

gemcitabine hydrochloride

topotecan hydrochloride

Study Description

Brief 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.

Detailed Description: 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.