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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Placebo; Drug: FOLFOX regimen; Drug: bevacizumab [Avastin]; Drug: 5-FU; Drug: leucovorin; Drug: onartuzumab [MetMAb]

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94105
      • Almac Clinical Technologies
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers; Bone and Marrow Trans
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists; SCRI
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Inst
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Georgia Cancer Specialists - Northside
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago; Hematology/Oncology
    • Harvey, Illinois, United States, 60426
      • Ingalls Cancer Research Center
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital; Cancer Research Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Baptist Hospital East
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Saint Louis Cancer Care, LLP
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center - Antibiotic Research Associates, Inc.
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Hem-Onc Assoc of Northern NJ
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care Inc
    • Toledo, Ohio, United States, 43623
      • Toledo Comm. Onc. Program
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma; Stephenson Oklahoma Canc Ctr
  • South Carolina
    • Columbia, South Carolina, United States, 29210
      • South Carolina Oncology Associates - SCRI
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • SCRI Tennessee Oncology Chattanooga
    • Nashville, Tennessee, United States, 37203
      • Tennessee Onc., PLLC - SCRI
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Ctr For Cancer And Blood Disorders
    • San Antonio, Texas, United States, 78229
      • South Texas Oncology & Hematology, P.A.
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Virginia Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Safety: Incidence of adverse events	up to 4 years
Overall survival	up to 4 years
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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Collaborators: SCRI Development Innovations, LLC

Publications and helpful links

General Publications

• Bendell JC, Hochster H, Hart LL, Firdaus I, Mace JR, McFarlane JJ, Kozloff M, Catenacci D, Hsu JJ, Hack SP, Shames DS, Phan SC, Koeppen H, Cohn AL. A Phase II Randomized Trial (GO27827) of First-Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer. Oncologist. 2017 Mar;22(3):264-271. doi: 10.1634/theoncologist.2016-0223. Epub 2017 Feb 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2011
• Primary Completion (Actual): March 18, 2013
• Study Completion (Actual): March 18, 2013

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimate): August 17, 2011

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Bevacizumab; Leucovorin
• Other Study ID Numbers: GO27827