drugset / Trial / NCT00191646

An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy

NCT00191646 ↗

Phase 3 Completed 919 enrolled Eli Lilly and Company
RandomizedCrossoverOpen-labelTreatment

Summary

This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.

Timeline

Start
2002-10
Primary completion
2009-08
Completion
2009-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Gemcitabine/Carboplatin vs Paclitaxel/Carboplatin; p = 0.199; Log Rank NCT00191646 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown —
Subject Carboplatin Small molecule 6 unknown —
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 135 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous