Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC)

Study Overview
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Brief Summary
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Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any 2nd-line chemotherapy were independently associated with increased overall survival (both p < 0.0001). Bevacizumab beyond progression appears to be associated with longer overall in BRiTE. The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond progression.

Detailed Description
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Patients should have been treated with bevacizumab plus chemotherapy as a 1st line treatment, and after 1st progression, these patients will be accrued in this study of bevacizumab plus chemotherapy as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.

Official Title
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Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Bevacizumab (Avastin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically documented colorectal adenocarcinoma Progression during first-line bevacizumab containing chemotherapy within 3 months No serious toxicity to bevacizumab of 1st line treatment Unresectable metastases Uni-dimensional measurable lesion(s) by RECIST Age over 18 years old ECOG 0-2 Adequate organ functions by clinical laboratory exams Exclusion Criteria: Other tumor type than adenocarcinoma CNS metastases GI bleeding Hypersensitivity to any of chemotherapeutic agents Prior use of cetuximab or other targeted agents other than bevacizumab Major surgery within 6 weeks Other serious illness

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br>Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy | Drug: Bevacizumab (Avastin)<br>* Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 6 weeks | 
| Toxicity profiles |  | 2 or 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, Bevacizumab