Back to resultsFOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5-FU
FOLFOX regimen
Placebo
bevacizumab [Avastin]
leucovorin
onartuzumab [MetMAb]
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- Almac Clinical Technologies
- Rocky Mountain Cancer Centers; Bone and Marrow Trans
- Florida Cancer Specialists; SCRI
- Florida Hospital Cancer Inst
- Georgia Cancer Specialists - Northside
- University of Chicago; Hematology/Oncology
- Ingalls Cancer Research Center
- Ingalls Memorial Hospital; Cancer Research Center
- Baptist Hospital East
- Center For Cancer and Blood Disorders
- Saint Louis Cancer Care, LLP
- Research Medical Center - Antibiotic Research Associates, Inc.
- Hem-Onc Assoc of Northern NJ
- Oncology Hematology Care Inc
- Toledo Comm. Onc. Program
- University of Oklahoma; Stephenson Oklahoma Canc Ctr
- South Carolina Oncology Associates - SCRI
- Spartanburg Regional Medical Center
- SCRI Tennessee Oncology Chattanooga
- Tennessee Onc., PLLC - SCRI
- Ctr for Cancer and Blood Disorders
- South Texas Oncology & Hematology, P.A.
- Virginia Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
Secondary Outcome Measures
Response rate (complete response + partial response)
Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death
Overall survival
Safety: Incidence of adverse events
Full Information
NCT ID
NCT01418222
First Posted
August 15, 2011
Last Updated
May 25, 2017
Sponsor
Genentech, Inc.
Collaborators
SCRI Development Innovations, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01418222
Brief Title
FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 14, 2011 (Actual)
Primary Completion Date
March 18, 2013 (Actual)
Study Completion Date
March 18, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
SCRI Development Innovations, LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
leucovorin
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
onartuzumab [MetMAb]
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Response rate (complete response + partial response)
Time Frame
up to 4 years
Title
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
Title
Overall survival
Time Frame
up to 4 years
Title
Safety: Incidence of adverse events
Time Frame
up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Almac Clinical Technologies
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
Facility Name
Rocky Mountain Cancer Centers; Bone and Marrow Trans
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Florida Cancer Specialists; SCRI
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Hospital Cancer Inst
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Georgia Cancer Specialists - Northside
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
University of Chicago; Hematology/Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ingalls Cancer Research Center
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Ingalls Memorial Hospital; Cancer Research Center
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Baptist Hospital East
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Center For Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Saint Louis Cancer Care, LLP
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Research Medical Center - Antibiotic Research Associates, Inc.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Hem-Onc Assoc of Northern NJ
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Oncology Hematology Care Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Toledo Comm. Onc. Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
University of Oklahoma; Stephenson Oklahoma Canc Ctr
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
South Carolina Oncology Associates - SCRI
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Onc., PLLC - SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Ctr for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
South Texas Oncology & Hematology, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28209746
Citation
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.
Results Reference
derived
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FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
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