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

Completed · Phase 2 · Has a placebo group

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT01418222

Run by

Genentech, Inc.

People needed

194

Starts

2011-09-14

Expected to finish

2013-03-18

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Almac Clinical Technologies — San Francisco, California, United States
• Rocky Mountain Cancer Centers; Bone and Marrow Trans — Denver, Colorado, United States
• Florida Cancer Specialists; SCRI — Fort Myers, Florida, United States
• Florida Hospital Cancer Inst — Orlando, Florida, United States
• Georgia Cancer Specialists - Northside — Atlanta, Georgia, United States
• University of Chicago; Hematology/Oncology — Chicago, Illinois, United States
• Ingalls Cancer Research Center — Harvey, Illinois, United States
• Ingalls Memorial Hospital; Cancer Research Center — Harvey, Illinois, United States
• Baptist Hospital East — Louisville, Kentucky, United States
• Center For Cancer and Blood Disorders — Bethesda, Maryland, United States
• Saint Louis Cancer Care, LLP — Bridgeton, Missouri, United States
• Research Medical Center - Antibiotic Research Associates, Inc. — Kansas City, Missouri, United States
• Hem-Onc Assoc of Northern NJ — Morristown, New Jersey, United States
• Oncology Hematology Care Inc — Cincinnati, Ohio, United States
• Toledo Comm. Onc. Program — Toledo, Ohio, United States
• University of Oklahoma; Stephenson Oklahoma Canc Ctr — Oklahoma City, Oklahoma, United States
• South Carolina Oncology Associates - SCRI — Columbia, South Carolina, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• SCRI Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
• Tennessee Onc., PLLC - SCRI — Nashville, Tennessee, United States
• Ctr for Cancer and Blood Disorders — Fort Worth, Texas, United States
• South Texas Oncology & Hematology, P.A. — San Antonio, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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