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NCT00118261 · ClinicalTrials.gov registry record · Phase 1
Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00118261: Completed Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT00118261 is a Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118261, a Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Erlotinib may help chemotherapy work better by making tumor cells more sensitive to the drugs. Giving erlotinib together with combination chemotherapy and bevacizumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with combination chemotherapy and bevacizumab as first-line therapy in treating patients with metastatic colorectal cancer.
Primary Outcome
Dose-limiting toxicities will be tracked in the first three cycles. The occurrence of DLT in 2 of the first 6 patients, 3 of the first 9 patients, or 4 of the first 12 patients (whichever occurs soonest)will require that subsequent patients are enrolled to the study at 100 mg erlotinib daily.
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
- BIOLOGICAL bevacizumab
- DRUG erlotinib hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-03 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT00118261 record still lists
NCT00118261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT00118261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00118261 about?
NCT00118261 is a clinical study titled "Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer". RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them fro...
What is the current status of trial NCT00118261?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2005-03. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00118261?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), bevacizumab (BIOLOGICAL), erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00118261?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00118261's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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