Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
NCT00061308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2017-06-09
Summary
This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.
Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.
Conditions
- Peritoneal Cancer
- Ovarian Cancer
- Neoplasms, Ovarian
- Fallopian Tube Cancer
Interventions
- DRUG
-
Topotecan
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials, MD, PhD · GlaxoSmithKline
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-12-31
- Primary Completion
- 2004-09-30
Countries
- United States
- Canada
Study Locations
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