drugset / Trial / NCT00191646
An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |