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NCT00941499 · ClinicalTrials.gov registry record · Phase 1
Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT00941499: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00941499 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00941499, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the best combination of oxaliplatin, bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with advanced cancer that has spread to the liver. Different combinations of these drugs will be used, and the safety of all drug combinations will also be studied.
Primary Outcome
If more than 33% of patients enrolled in any particular dose level develop DLT, the treatment will continue at the dose level immediately below. If not more than 33% of the patients in the cohort develop DLT, this cohort will be considered the MTD. DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in NCI CTC v3.0, any Grade 4 hematologic toxicity lasting at least 3 weeks or longer (as defined by the NCI CTC), despite supportive care or associated with bleeding and/or sepsis; an
Interventions
- DRUG Bevacizumab
- DRUG Leucovorin
- DRUG Cetuximab
- DRUG 5-FU
- DRUG HAI Oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT00941499 record still lists
NCT00941499 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT00941499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00941499 about?
NCT00941499 is a clinical study titled "Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab". The goal of this clinical research study is to find the best combination of oxaliplatin, bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with advanced cancer that has spread to the liver. Different combinations of these drugs will be used, and the safety of all d...
What is the current status of trial NCT00941499?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2009-07. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00941499?
The interventions under investigation include: Bevacizumab (DRUG), Leucovorin (DRUG), Cetuximab (DRUG), 5-FU (DRUG), HAI Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT00941499?
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 NCT00941499's enrollment target sits among peer trials
140 402nd of 2000 higher than 1,583 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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