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NCT00191646 · ClinicalTrials.gov registry record · Phase 3
An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 919
- Enrollment target
NCT00191646: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT00191646 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 919 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00191646, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 919 participants
- Enrollment target
Study 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.
Primary Outcome
Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy fol
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 919 participants |
| Start Date | 2002-10 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00191646 record still lists
NCT00191646 is an interventional study that assigns participants to a tested intervention. The registered 919 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT00191646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00191646 about?
NCT00191646 is a clinical study titled "An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy". 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...
What is the current status of trial NCT00191646?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 919 participants. The study started on 2002-10. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00191646?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00191646?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00191646's enrollment target sits among peer trials
919 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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