Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00069095 · ClinicalTrials.gov registry record · Phase 3
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,035
- Enrollment target
NCT00069095: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00069095 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 2,035 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (164% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00069095, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,035 participants
- Enrollment target
Study Summary
This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m\^2 orally \[po\] twice a day \[bid\] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil \[5-FU\] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).
Primary Outcome
PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored
Interventions
- DRUG Oxaliplatin 85 mg/m^2
- DRUG Bevacizumab 7.5 mg/kg
- DRUG Oxaliplatin 130 mg/m^2
- DRUG Capecitabine 1000 mg/m^2
- DRUG Placebo for bevacizumab 7.5 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,035 participants |
| Start Date | 2003-07 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00069095 record still lists
NCT00069095 is an interventional study that assigns participants to a tested intervention. Its 2,035 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (164% higher).
The record links to 0 conditions, and to 5 interventions - of which Oxaliplatin 85 mg/m^2 is the first listed.
NCT00069095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00069095 about?
NCT00069095 is a clinical study titled "A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer". This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were ...
What is the current status of trial NCT00069095?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,035 participants. The study started on 2003-07. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00069095?
The interventions under investigation include: Oxaliplatin 85 mg/m^2 (DRUG), Bevacizumab 7.5 mg/kg (DRUG), Oxaliplatin 130 mg/m^2 (DRUG), Capecitabine 1000 mg/m^2 (DRUG), Placebo for bevacizumab 7.5 mg/kg (DRUG).
Who is sponsoring clinical trial NCT00069095?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00069095's enrollment target sits among peer trials
2,035 100th of 2000 higher than 1,901 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
- NCT05625659 · 2,032 participants · NA
Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
- NCT06825897 · 2,039 participants · NA
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
- NCT04216732 · 2,030 participants
Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management
- NCT05138718 · 2,041 participants
FDG an Myocardial Infarction: The PIAF Trial
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