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NCT00538291 · ClinicalTrials.gov registry record · Phase 2
Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment
A Phase 2 study, sponsored by City of Hope Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00538291: Clinical Trial Phase 2 study, sponsored by City of Hope Medical Center.
NCT00538291 is a Phase 2 study that was terminated before completion, run by City of Hope Medical Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00538291, a Phase 2 study, was terminated before completion, sponsored by City of Hope Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies such as cetuximab, 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 colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with capecitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine work in treating patients with metastatic colorectal cancer.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: 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
- GENETIC gene expression analysis
- GENETIC microarray analysis
- BIOLOGICAL cetuximab
- DRUG capecitabine
- GENETIC polymorphism analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2005-08 |
| Phase | Phase 2 |
Why NCT00538291 stopped before completion
NCT00538291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which gene expression analysis is the first listed.
NCT00538291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00538291 about?
NCT00538291 is a clinical study titled "Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment". RATIONALE: Monoclonal antibodies such as cetuximab, 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 colorectal cancer by blo...
What is the current status of trial NCT00538291?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2005-08.
What interventions are being tested in trial NCT00538291?
The interventions under investigation include: gene expression analysis (GENETIC), microarray analysis (GENETIC), cetuximab (BIOLOGICAL), capecitabine (DRUG), polymorphism analysis (GENETIC).
Who is sponsoring clinical trial NCT00538291?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00538291's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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