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NCT00193219 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00193219: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT00193219 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00193219, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an earlier treatment setting in combination with optimal chemotherapy regimens is an important emerging question.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Interventions
- DRUG Bevacizumab
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Cetuximab
- DRUG 5-fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2005-07 |
| Est. Completion | 2010-07 |
| Phase | Phase 2 |
What the finished NCT00193219 record still lists
NCT00193219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT00193219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00193219 about?
NCT00193219 is a clinical study titled "Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer". This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. Th...
What is the current status of trial NCT00193219?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2005-07. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00193219?
The interventions under investigation include: Bevacizumab (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Cetuximab (DRUG), 5-fluorouracil (DRUG).
Who is sponsoring clinical trial NCT00193219?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00193219's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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