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NCT00645593 · ClinicalTrials.gov registry record · Phase 2
Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
NCT00645593: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00645593 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00645593, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
Study Summary
This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine and Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which treatment is better.
Primary Outcome
The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab. Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions).
Interventions
- DRUG Cisplatin
- DRUG Cetuximab
- DRUG Gemcitabine,
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2008-03 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT00645593 record still lists
NCT00645593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00645593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00645593 about?
NCT00645593 is a clinical study titled "Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer". This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine and Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which treatment is better.
What is the current status of trial NCT00645593?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2008-03. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00645593?
The interventions under investigation include: Cisplatin (DRUG), Cetuximab (DRUG), Gemcitabine, (DRUG).
Who is sponsoring clinical trial NCT00645593?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00645593's enrollment target sits among peer trials
89 802nd of 2000 higher than 1,198 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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