A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

Official Title
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A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Chemotherapy
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >=18 years of age Metastatic colorectal cancer and disease progression Previously treated with first-line chemotherapy plus Avastin Eastern Cooperative Oncology Group (ECOG) performance status <=2. Exclusion Criteria: Diagnosis of progression of disease more than 3 months after last Avastin administration First-line patients with progression-free survival in first-line of <3 months Patients receiving less than 3 consecutive months of Avastin in first-line therapy Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix Clinically significant cardiovascular disease within 6 months prior to start of study treatment Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol

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 |
| --- | --- |
| Active Comparator: Chemotherapy<br>Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal | Drug: Chemotherapy<br>* As prescribed<br>|
| Experimental: Chemotherapy + Bevacizumab<br>Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal | Drug: Chemotherapy<br>* As prescribed<br>Drug: Bevacizumab<br>* Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival: Time From Randomization to Death From Any Cause |  | within 6.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival: Months From Time of First Line Therapy |  | within approximately 9.6 years | 
| Participants With Progression Free Survival Event |  | within 6.5 years | 
| Progression Free Survival: Time to Event |  | within 6.5 years | 
| Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria |  | within 6.5 years | 
| Response Rate: Participants With Response Status Based on RECIST Criteria | Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. | within 6.5 years |