A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube
- 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
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
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
Primary Purpose: Treatment
Ming-teh D. Chen, MD
Women's Cancer Center - Los Gatos
United States: Federal Government
|Chao Family Comprehensive Cancer Center||Orange, California 92868|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|Women's Cancer Center||Palo Alto, California 94304|
|Community Hospital of Los Gatos||Los Gatos, California 95032|
|Holden Comprehensive Cancer Center at The University of Iowa||Iowa City, Iowa 52242-1009|