A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine [Xeloda]
* Drug: capecitabine [Xeloda]
* Drug: bevacizumab [Avastin]
* Drug: oxaliplatin
* Drug: irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XELOX + bevacizumab (Q2W)<br> | Drug: capecitabine [Xeloda]<br>* 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle<br>Drug: bevacizumab [Avastin]<br>* 5 mg/kg taken intravenously on Day 1 of each 2 week cycle<br>Drug: oxaliplatin<br>* 85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles<br>|
| Experimental: XELIRI + bevacizumab (Q2W)<br> | Drug: capecitabine [Xeloda]<br>* 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle<br>Drug: bevacizumab [Avastin]<br>* 5 mg/kg taken intravenously on Day 1 of each 2 week cycle<br>Drug: irinotecan<br>* 135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) in U.S. Patients Only | 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. | From first patient enrolled up to approximately 48 months |