NCT00316173

Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer

An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.

Conditions

• Ovarian Cancer
• Neoplasms, Ovarian

Interventions

Type	Name	Description
DRUG	topotecan	HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1
DRUG	CARBOPLATIN	HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1

Timeline

• Start date: 2005-03-01
• Primary completion: 2009-01-01
• Completion: 2009-03-01
• First posted: 2006-04-20
• Last updated: 2012-11-27
• Results posted: 2009-11-26

Locations

22 sites across 2 countries: United States, Canada