NCT00061308

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

An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Topotecan
DRUG	Gemcitabine

Timeline

• Start date: 2002-12-01
• Primary completion: 2004-09-01
• First posted: 2003-05-28
• Last updated: 2017-06-09

Locations

19 sites across 2 countries: United States, Canada