A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.

Study Overview
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Brief Summary
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This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.

Official Title
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A Randomized, Open Label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Irinotecan + 5-fluorouracil/Folinic Acid, and Irinotecan + 5-fluorouracil/Folinic Acid Alone, on Progression-free Survival in Chinese Patients With Metastatic Colorectal Cancer.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: bevacizumab [Avastin]
* Drug: irinotecan
* Drug: leucovorin
* Drug: fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >=18 years of age; histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease; >=1 measurable lesion; ECOG performance status of <=1. Exclusion Criteria: prior systemic therapy for advanced or metastatic disease; adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months; other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix; clinically significant cardiovascular disease in past 6 months.

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: bevacizumab [Avastin]<br>* 5mg/kg iv every 2 weeks<br>Drug: irinotecan<br>* 125mg/m2 iv weekly for 4 weeks of each 6 week cycle<br>Drug: leucovorin<br>* 20mg/m2 iv weekly for 4 weeks of each 6 week cycle<br>Drug: fluorouracil<br>* 500mg/m2 iv weekly for 4 weeks of each 6 week cycle<br>|
| Active Comparator: 2<br> | Drug: irinotecan<br>* 125mg/m2 iv weekly for 4 weeks of each 6 week cycle<br>Drug: leucovorin<br>* 20mg/m2 iv weekly for 4 weeks of each 6 week cycle<br>Drug: fluorouracil<br>* 500mg/m2 iv weekly for 4 weeks of each 6 week cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate, time to response, duration of response, overall survival. |  | Event driven | 
| AEs, laboratory tests |  | Throughout study |