drugset / Trial / NCT00314678

Cisplatin Induction With Paclitaxel Consolidation for Stage III-IV Epithelial Ovarian and Primary Peritoneal Cancer

NCT00314678 ↗

Phase 2 Completed 40 enrolled John P. Fruehauf GlaxoSmithKline · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Clinically, there has been extensive experience with topotecan and cisplatin. Recently, several investigators have evaluated the combination of paclitaxel, cisplatin and topotecan. As expected, myelosuppression was the dose-limiting factor. Herben et al recently reported the results of a phase I trial using the combination of paclitaxel, cisplatin, and topotecan as first line therapy in advanced stage ovarian cancer. Interestingly, the authors could not achieve a dose of topotecan that would be considered "optimal" for the treatment of relapsed disease in a single-agent fashion. The inability to utilize a therapeutic dose when combined with either platinum or paclitaxel has been demonstrated in previous reports and affirms the bone marrow suppressive effect. The clinical response rate from this trial was reported as 86.7%.

Timeline

Start
2005-09
Primary completion
—
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified — —
Subject Paclitaxel Small molecule — —
Subject Topotecan Small molecule — —