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NCT00265850 · ClinicalTrials.gov registry record · Phase 3
Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,334
- Enrollment target
NCT00265850: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00265850 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 2,334 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (202% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00265850, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,334 participants
- Enrollment target
Study Summary
PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.
Primary Outcome
Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.
Interventions
- DRUG FOLFIRI
- BIOLOGICAL cetuximab
- BIOLOGICAL bevacizumab
- DRUG FOLFOX or
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,334 participants |
| Start Date | 2005-11 |
| Est. Completion | 2018-01 |
| Phase | Phase 3 |
What the finished NCT00265850 record still lists
NCT00265850 is an interventional study that assigns participants to a tested intervention. Its 2,334 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (202% higher).
The record links to 0 conditions, and to 4 interventions - of which FOLFIRI is the first listed.
NCT00265850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00265850 about?
NCT00265850 is a clinical study titled "Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer". PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tu...
What is the current status of trial NCT00265850?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,334 participants. The study started on 2005-11. Estimated completion is 2018-01.
What interventions are being tested in trial NCT00265850?
The interventions under investigation include: FOLFIRI (DRUG), cetuximab (BIOLOGICAL), bevacizumab (BIOLOGICAL), FOLFOX or (DRUG).
Who is sponsoring clinical trial NCT00265850?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00265850's enrollment target sits among peer trials
2,334 92nd of 2000 higher than 1,909 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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