drugset / Trial / NCT00102414

Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer

NCT00102414 ↗

Phase 3 Completed 356 enrolled AGO Study Group
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6 months after treatment discontinuation.

Timeline

Start
1999-09
Primary completion
—
Completion
2004-11

Outcome

Met primary endpoint

paper CONCLUSION: Gemcitabine plus carboplatin significantly improves PFS and response rate without worsening quality of life for patients with platinum-sensitive recurrent ovarian cancer. PMID 16966687 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule — —

Indications