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NCT00354978 · ClinicalTrials.gov registry record · Phase 2
Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00354978: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00354978 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00354978, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
Objectives: 1. To estimate progression-free survival (PFS) at 12 months in subjects with metastatic colorectal cancer who receive FOLFIRI \[folinic acid (leucovorin or LV), 5-Fluorouracil (5-FU), irinotecan) plus bevacizumab as first line treatment. 2. To determine the objective response rate and the duration of objective response in this population. 3. To assess overall survival (OS) in this population. 4. To measure the effect of treatment on intratumoral blood volume and microvascular permeability by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in consenting patients in whom it is technically feasible. 5. To correlate plasma proteomics with response. 6. To assess the safety of this regimen.
Primary Outcome
PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.
Interventions
- DRUG Bevacizumab
- DRUG Leucovorin
- DRUG Irinotecan
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2005-01 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT00354978 record still lists
NCT00354978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00354978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00354978 about?
NCT00354978 is a clinical study titled "Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients". Objectives: 1. To estimate progression-free survival (PFS) at 12 months in subjects with metastatic colorectal cancer who receive FOLFIRI \[folinic acid (leucovorin or LV), 5-Fluorouracil (5-FU), irinotecan) plus bevacizumab as first line treatment. 2. To determine the objective response rate and t...
What is the current status of trial NCT00354978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2005-01. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00354978?
The interventions under investigation include: Bevacizumab (DRUG), Leucovorin (DRUG), Irinotecan (DRUG), 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT00354978?
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 NCT00354978's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 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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