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



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:September 2011
End Date:March 2013

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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

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.


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
- Significant cardiovascular disease or disorder

- History of abdominal fistula or gastrointestinal perforation 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
We found this trial at
22
sites
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Chattanooga, TN
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Chicago, IL
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Columbia, SC
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Denver, CO
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Fort Myers, FL
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Fort Worth, TX
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Harvey, IL
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Kansas City, MO
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Louisville, KY
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Morristown, NJ
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Nashville, TN
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Oklahoma City, OK
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Orlando, FL
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Richmond, VA
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San Antonio, TX
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San Francisco, CA
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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Toledo, OH
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