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
1 other identifier
interventional
194
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Sep 2011
Shorter than P25 for phase_2 colorectal-cancer
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedStudy Start
First participant enrolled
September 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2013
CompletedMay 30, 2017
May 1, 2017
1.5 years
August 15, 2011
May 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
up to 4 years
Secondary Outcomes (4)
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
Overall survival
up to 4 years
Safety: Incidence of adverse events
up to 4 years
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
- SCRI Development Innovations, LLCcollaborator
Study Sites (23)
Almac Clinical Technologies
San Francisco, California, 94105, United States
Rocky Mountain Cancer Centers; Bone and Marrow Trans
Denver, Colorado, 80218, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, 33901, United States
Florida Hospital Cancer Inst
Orlando, Florida, 32804, United States
Georgia Cancer Specialists - Northside
Atlanta, Georgia, 30341, United States
University of Chicago; Hematology/Oncology
Chicago, Illinois, 60637, United States
Ingalls Cancer Research Center
Harvey, Illinois, 60426, United States
Ingalls Memorial Hospital; Cancer Research Center
Harvey, Illinois, 60426, United States
Baptist Hospital East
Louisville, Kentucky, 40207, United States
Center For Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Saint Louis Cancer Care, LLP
Bridgeton, Missouri, 63044, United States
Research Medical Center - Antibiotic Research Associates, Inc.
Kansas City, Missouri, 64132, United States
Hem-Onc Assoc of Northern NJ
Morristown, New Jersey, 07960, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
Toledo Comm. Onc. Program
Toledo, Ohio, 43623, United States
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Oklahoma City, Oklahoma, 73104, United States
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, 29210, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, 37203, United States
Ctr for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
South Texas Oncology & Hematology, P.A.
San Antonio, Texas, 78229, United States
Virginia Cancer Institute
Richmond, Virginia, 23226, United States
Related Publications (1)
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.
PMID: 28209746DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2011
First Posted
August 17, 2011
Study Start
September 14, 2011
Primary Completion
March 18, 2013
Study Completion
March 18, 2013
Last Updated
May 30, 2017
Record last verified: 2017-05