FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.

Official Title
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Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: 5-FU
* Drug: FOLFOX regimen
* Drug: Placebo
* Drug: bevacizumab [Avastin]
* Drug: leucovorin
* Drug: onartuzumab [MetMAb]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Measurable disease by RECIST criteria Adequate organ system function, as defined by protocol Exclusion Criteria: Prior systemic or radiation therapy for metastatic colorectal cancer Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease Previously untreated brain metastases History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) History of hematemesis or hemoptysis </= 1 months prior to study enrollment Significant cardiovascular disease or disorder History of abdominal fistula or gastrointestinal perforation </= 6 months prior to Day 1 Positive for hepatitis B, hepatitis C or HIV infection Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: 5-FU<br>* Intravenous repeating dose<br>Drug: FOLFOX regimen<br>* Intravenous repeating dose<br>Drug: bevacizumab [Avastin]<br>* Intravenous repeating dose<br>Drug: leucovorin<br>* Intravenous repeating dose<br>Drug: onartuzumab [MetMAb]<br>* Intravenous repeating dose<br>|
| Active Comparator: B<br> | Drug: 5-FU<br>* Intravenous repeating dose<br>Drug: FOLFOX regimen<br>* Intravenous repeating dose<br>Drug: Placebo<br>* Intravenous repeating dose<br>Drug: bevacizumab [Avastin]<br>* Intravenous repeating dose<br>Drug: leucovorin<br>* Intravenous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria |  | up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (complete response + partial response) |  | up to 4 years | 
| Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death |  | up to 4 years | 
| Overall survival |  | up to 4 years | 
| Safety: Incidence of adverse events |  | up to 4 years |