drugset / Trial / NCT00061308

Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer

NCT00061308 ↗

Phase 2 Completed 75 enrolled GlaxoSmithKline
Non-randomizedOpen-labelTreatment

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.

Timeline

Start
2002-12
Primary completion
2004-09
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule — Intravenous
Subject Topotecan Small molecule — Intravenous