Clinical trial NCT01418222: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: SCRI Development Innovations, LLC
First posted: 2011-08-17
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
timeFrame: up to 4 years
Secondary outcomes:
measure: Response rate (complete response + partial response)
timeFrame: up to 4 years
measure: Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death
timeFrame: up to 4 years
measure: Overall survival
timeFrame: up to 4 years
measure: Safety: Incidence of adverse events
timeFrame: up to 4 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Almac Clinical Technologies
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers; Bone and Marrow Trans
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists; SCRI
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Inst
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialists - Northside
state: Georgia
city: Chicago
country: United States
facility: University of Chicago; Hematology/Oncology
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Research Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital; Cancer Research Center
state: Illinois
city: Louisville
country: United States
facility: Baptist Hospital East
state: Kentucky
city: Bethesda
country: United States
facility: Center For Cancer and Blood Disorders
state: Maryland
city: Bridgeton
country: United States
facility: Saint Louis Cancer Care, LLP
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center - Antibiotic Research Associates, Inc.
state: Missouri
city: Morristown
country: United States
facility: Hem-Onc Assoc of Northern NJ
state: New Jersey
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc
state: Ohio
city: Toledo
country: United States
facility: Toledo Comm. Onc. Program
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr
state: Oklahoma
city: Columbia
country: United States
facility: South Carolina Oncology Associates - SCRI
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Onc., PLLC - SCRI
state: Tennessee
city: Fort Worth
country: United States
facility: Ctr for Cancer and Blood Disorders
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology & Hematology, P.A.
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.