A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Official Title
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A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: Oxaliplatin
* Drug: bevacizumab
* Drug: capecitabine
* Drug: Oxaliplatin
* Drug: bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic or inoperable locally advanced colorectal cancer >=1 measurable target lesion Exclusion Criteria: Previous systemic therapy for advanced or metastatic disease Previous treatment with bevacizumab

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: 1<br> | Drug: capecitabine<br>* 850 mg/m^2 po bid on Days 1-14 of each 3-week cycle<br>Drug: Oxaliplatin<br>* 130 mg/m^2 IV on Day 1 of each 3-week cycle<br>Drug: bevacizumab<br>* 7.5 mg/kg IV on Day 1 of each 3-week cycle<br>|
| Active Comparator: 2<br> | Drug: capecitabine<br>* 1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle<br>Drug: Oxaliplatin<br>* 85 mg/m^2 IV on Day 1 of each 2-week cycle<br>Drug: bevacizumab<br>* 5 mg/kg IV on Day 1 of each 2-week cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST). | Time to disease progression or death (through follow-up phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death, for any cause. | Time to death (through follow-up phase): Approximate Median of 718 days | 
| Best Overall Clinical Response | Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered responders), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. | Through follow-up phase: Approximate Median of 318 days | 
| Duration of Overall Clinical Response (CR or PR) | Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause. | Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days |