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NCT00098787 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 247
- Enrollment target
NCT00098787: Completed Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
NCT00098787 is a Phase 2 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 247 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00098787, a Phase 2 study, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 247 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, 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. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the best treatment. PURPOSE: This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating patients with metastatic or recurrent colorectal cancer.
Primary Outcome
Objective response rate is defined as proportion of patients who achieve complete response (CR) or partial response (PR). Response was assessed using Solid Tumor Response Criteria (RECIST). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Interventions
- DRUG Oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
- BIOLOGICAL bevacizumab
- DRUG irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2005-09-08 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT00098787 record still lists
NCT00098787 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher).
The record links to 0 conditions, and to 5 interventions - of which Oxaliplatin is the first listed.
NCT00098787 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00098787 about?
NCT00098787 is a clinical study titled "Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer". RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, 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 differe...
What is the current status of trial NCT00098787?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2005-09-08. Estimated completion is 2015-04.
What interventions are being tested in trial NCT00098787?
The interventions under investigation include: Oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), bevacizumab (BIOLOGICAL), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00098787?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00098787's enrollment target sits among peer trials
247 234th of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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