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 |
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.
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 = 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
We found this trial at
22
sites
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