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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 2,035 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069095
The ClinicalTrials.gov registry entry for NCT00069095 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,035 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Oxaliplatin 85 mg/m^2 is the first listed.
NCT00069095 reports 0 study locations.
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.
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