Clinical trial · Interventional
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in 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 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab [Avastin] | Drug | Bevacizumab | ALIAS |
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- XELOX + bevacizumab (Q2W)
- interventionNames
- Drug: capecitabine [Xeloda]
- Drug: bevacizumab [Avastin]
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- XELIRI + bevacizumab (Q2W)
- interventionNames
- Drug: capecitabine [Xeloda]
- Drug: bevacizumab [Avastin]
- Drug: irinotecan
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) in U.S. Patients Only
- timeFrame
- From first patient enrolled up to approximately 48 months
- description
- PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, ≥18 years of age * Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease * ≥1 measurable target lesion * Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 Exclusion Criteria: * Prior systemic therapy for advanced or metastatic disease * History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix * Clinically significant cardiovascular disease * Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents * Chronic daily treatment with \>325 mg/day aspirin
References
Publications (0)
Data not yet available