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NCT00307736 · ClinicalTrials.gov registry record · Phase 1
Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00307736: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT00307736 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00307736, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II portion) patients with locally advanced rectal cancer.
Primary Outcome
MTD of Erlotinib was determined using a traditional 3 + 3 dose escalation scheme of three dose levels (50,100,150mg). Successive cohorts of 3-6 patients were enrolled into dose escalation cohorts for 14 day cycles. MTD reflects the highest dose of Erlotinib that had ≤1 out of 6 patients with Dose-Limiting Toxicity (DLT) at the highest dose level below the maximally administered dose. The maximally administered dose is the first dose that causes DLT in \>33% of patients. DLT was defined as: Any g
Interventions
- DRUG 5-fluorouracil
- DRUG bevacizumab
- DRUG erlotinib
- PROCEDURE External beam radiation therapy (EBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2006-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT00307736 record still lists
NCT00307736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which 5-fluorouracil is the first listed.
NCT00307736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00307736 about?
NCT00307736 is a clinical study titled "Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer". The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II ...
What is the current status of trial NCT00307736?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2006-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00307736?
The interventions under investigation include: 5-fluorouracil (DRUG), bevacizumab (DRUG), erlotinib (DRUG), External beam radiation therapy (EBRT) (PROCEDURE).
Who is sponsoring clinical trial NCT00307736?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00307736's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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