Clinical trial · Interventional
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer
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") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab 5 mg/kg | Drug | Bevacizumab | ALIAS |
| Bevacizumab 7.5 mg/kg | Drug | Bevacizumab | ALIAS |
| Capecitabine 1000 mg/m^2 | Drug | — | UNRESOLVED |
| Fluorouracil 400 mg/m^2 | Drug | — | UNRESOLVED |
| Leucovorin 200 mg/m^2 | Drug | — | UNRESOLVED |
| Oxaliplatin 130 mg/m^2 | Drug | — | UNRESOLVED |
| Oxaliplatin 85 mg/m^2 | Drug | — | UNRESOLVED |
| Placebo for bevacizumab 5 mg/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- XELOX (oxaliplatin+capecitabine)
- description
- Patients in the 2-arm part of the study received oxaliplatin 130 mg/m\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\^2 orally twice a day for the first 2 weeks of every 3 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.
- interventionNames
- Drug: Oxaliplatin 130 mg/m^2
- Drug: Capecitabine 1000 mg/m^2
- Drug: Placebo for bevacizumab 7.5 mg/kg
- type
- EXPERIMENTAL
- label
- XELOX (oxaliplatin+capecitabine) + bevacizumab
- description
- Patients in the 4-arm part of the study received oxaliplatin 130 mg/m\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\^2 orally twice a day for the first 2 weeks of every 3 week cycle + bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.
- interventionNames
- Drug: Oxaliplatin 130 mg/m^2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients ≥ 18 years of age. * Metastatic colorectal cancer. * ≥ 1 target lesion. Exclusion Criteria: * Previous treatment with oxaliplatin or bevacizumab. * Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease. * Progressive disease during or within 6 months of completion of previous adjuvant therapy.
References
Publications (0)
Data not yet available