Clinical trial
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in…
NCT00069095 · Hoffmann-La Roche, Industry · Completed
Key facts
| NCT number | NCT00069095 |
|---|---|
| Title | A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer |
| Official title | A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4")… |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Colorectal Cancer |
| Intervention type | Drug |
| Interventions | Oxaliplatin 130 mg/m^2, Capecitabine 1000 mg/m^2, Bevacizumab 7.5 mg/kg, Placebo for bevacizumab 7.5 mg/kg, Oxaliplatin 85 mg/m^2, Leucovorin 200 mg/m^2, Fluorouracil 400 mg/m^2, Bevacizumab 5 mg/kg, Placebo for bevacizumab 5 mg/kg |
| Enrollment | 2,035 |
| Start date | Jul 1, 2003 |
| Primary completion | Jan 1, 2006 |
| Completion | Apr 1, 2009 |
| First posted | Sep 18, 2003 |
| Last update posted | Oct 6, 2016 |
| Countries | Australia, Austria, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Guatemala, Hong Kong and 21 more |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: