Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
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.
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: filgrastim Drug: gemcitabine hydrochloride Drug: topotecan hydrochloride||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube|
|Study Start Date:||May 1998|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003382
|United States, California|
|Community Hospital of Los Gatos|
|Los Gatos, California, United States, 95032|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Women's Cancer Center|
|Palo Alto, California, United States, 94304|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Iowa|
|Holden Comprehensive Cancer Center at The University of Iowa|
|Iowa City, Iowa, United States, 52242-1009|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Ming-teh D. Chen, MD||Women's Cancer Center - Los Gatos|