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NCT02292758 · ClinicalTrials.gov registry record · Phase 2
Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
A Phase 2 study, sponsored by Academic and Community Cancer Research United.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT02292758: Completed Phase 2 study, sponsored by Academic and Community Cancer Research United.
NCT02292758 is a Phase 2 study that has completed, run by Academic and Community Cancer Research United. 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
NCT02292758, a Phase 2 study, has completed, sponsored by Academic and Community Cancer Research United.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well irinotecan and cetuximab with or without bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to other places in the body (locally advanced/metastatic) and cannot be removed by surgery. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cetuximab and bevacizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in treating patients with colorectal cancer.
Primary Outcome
The distribution of PFS by group will be estimated using the method of Kaplan-Meier. Median by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The hazard ratio (HR) with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) ver
Interventions
- OTHER Placebo
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- DRUG Irinotecan
- BIOLOGICAL Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-12-12 |
| Est. Completion | 2019-09-27 |
| Phase | Phase 2 |
What the finished NCT02292758 record still lists
NCT02292758 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 Placebo is the first listed.
NCT02292758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02292758 about?
NCT02292758 is a clinical study titled "Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery". This randomized phase II trial studies how well irinotecan and cetuximab with or without bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to other places in the body (locally advanced/metastatic) and cannot be removed by surgery. Irinotecan may stop the grow...
What is the current status of trial NCT02292758?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2014-12-12. Estimated completion is 2019-09-27.
What interventions are being tested in trial NCT02292758?
The interventions under investigation include: Placebo (OTHER), Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Irinotecan (DRUG), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02292758?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02292758'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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