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

This study has been completed.
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: August 15, 2011
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Colorectal Cancer
Drug: 5-FU
Drug: FOLFOX regimen
Drug: Placebo
Drug: bevacizumab [Avastin]
Drug: leucovorin
Drug: onartuzumab [MetMAb]
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria [ Time Frame: up to 4 years ]

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

Enrollment: 194
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: 5-FU
Intravenous repeating dose
Drug: FOLFOX regimen
Intravenous repeating dose
Drug: bevacizumab [Avastin]
Intravenous repeating dose
Drug: leucovorin
Intravenous repeating dose
Drug: onartuzumab [MetMAb]
Intravenous repeating dose
Active Comparator: B Drug: 5-FU
Intravenous repeating dose
Drug: FOLFOX regimen
Intravenous repeating dose
Drug: Placebo
Intravenous repeating dose
Drug: bevacizumab [Avastin]
Intravenous repeating dose
Drug: leucovorin
Intravenous repeating dose


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01418222

  Show 22 Study Locations
Sponsors and Collaborators
Genentech, Inc.
SCRI Development Innovations, LLC
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01418222     History of Changes
Other Study ID Numbers: GO27827
Study First Received: August 15, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors processed this record on May 22, 2017