Ovarian Cancer Clinical Trial
Official title:
A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube
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.
;
Primary Purpose: Treatment
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