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NCT00642603 · ClinicalTrials.gov registry record · Phase 2
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00642603: Clinical Trial Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00642603 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00642603, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
Primary Outcome
PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.
Interventions
- DRUG oxaliplatin
- DRUG irinotecan
- DRUG capecitabine [Xeloda]
- DRUG bevacizumab [Avastin]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
Why NCT00642603 stopped before completion
NCT00642603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 4 interventions - of which oxaliplatin is the first listed.
NCT00642603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00642603 about?
NCT00642603 is a clinical study titled "A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer". This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-we...
What is the current status of trial NCT00642603?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2008-05. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00642603?
The interventions under investigation include: oxaliplatin (DRUG), irinotecan (DRUG), capecitabine [Xeloda] (DRUG), bevacizumab [Avastin] (DRUG).
Who is sponsoring clinical trial NCT00642603?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00642603's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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