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NCT00543842 · ClinicalTrials.gov registry record · Phase 1
Bevacizumab, Erlotinib, and Capecitabine for Locally Advanced Rectal Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00543842: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00543842 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00543842, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of bevacizumab (Avastin) and erlotinib hydrochloride (Tarceva) that can be given in combination with standard radiation therapy and capecitabine before surgery to patients with rectal cancer. The safety and effectiveness of this combination of therapies will also be studied. The goal of this Phase I trial was to determine the maximal tolerated dose (MTD) of concurrent capecitabine, bevacizumab and erlotinib with preoperative radiation therapy (RT) for rectal cancer. The trial completed as Phase I without progressing to the Phase II portion.
Primary Outcome
MTD derived from differing dose combinations of Capecitabine, Bevacizumab, and Erlotinib of using the continual reassessment method (CRM). Dose limiting toxicity defined as any grade 3 or higher acute toxicity during chemoradiation. The MTD will be defined as the dose at which grade 3 or higher acute toxicity exceeds 25%.
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
- RADIATION Radiation Therapy
- PROCEDURE Surgery
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2007-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT00543842 record still lists
NCT00543842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT00543842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00543842 about?
NCT00543842 is a clinical study titled "Bevacizumab, Erlotinib, and Capecitabine for Locally Advanced Rectal Cancer". The goal of this clinical research study is to find the highest tolerable dose of bevacizumab (Avastin) and erlotinib hydrochloride (Tarceva) that can be given in combination with standard radiation therapy and capecitabine before surgery to patients with rectal cancer. The safety and effectiveness ...
What is the current status of trial NCT00543842?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2007-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00543842?
The interventions under investigation include: Bevacizumab (DRUG), Capecitabine (DRUG), Radiation Therapy (RADIATION), Surgery (PROCEDURE), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00543842?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00543842's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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