Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00499369 · ClinicalTrials.gov registry record · Phase 3
Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT00499369: Clinical Trial Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00499369 is a Phase 3 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00499369, a Phase 3 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemotherapy, such as irinotecan, 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 cetuximab and 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.
Primary Outcome
PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Interventions
- DRUG fluorouracil
- BIOLOGICAL cetuximab
- DRUG leucovorin calcium
- BIOLOGICAL bevacizumab
- DRUG irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2007-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
Why NCT00499369 stopped before completion
NCT00499369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which fluorouracil is the first listed.
NCT00499369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00499369 about?
NCT00499369 is a clinical study titled "Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy". This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemother...
What is the current status of trial NCT00499369?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2007-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00499369?
The interventions under investigation include: fluorouracil (DRUG), cetuximab (BIOLOGICAL), leucovorin calcium (DRUG), bevacizumab (BIOLOGICAL), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00499369?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00499369's enrollment target sits among peer trials
72 1780th of 2000 higher than 217 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia