NCT00170677

Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: North Eastern German Society of Gynaecological Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Detailed description

Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Topotecan	Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
DRUG	Topotecan	Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.

Timeline

• Start date: 2005-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2005-09-15
• Last updated: 2014-05-14

Locations

1 site across 1 country: Germany