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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: 5-FU; Drug: FOLFOX regimen; Drug: bevacizumab [Avastin]; Drug: Placebo; Drug: leucovorin; Drug: onartuzumab [MetMAb]

• Registration Number: NCT01418222
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Study Start: 2011-09-14
• Primary Completion: 2013-03-18
• Study Completion: 2013-03-18
• Disposition First Submitted: 2016-08-09
• Disposition First Submitted QC: 2016-08-09
• Disposition First Posted: 2016-08-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	bevacizumab [Avastin]	-
B	5-FU	-
B	Placebo	-
B	bevacizumab [Avastin]	-
A	onartuzumab [MetMAb]	-
A	FOLFOX regimen	-
B	FOLFOX regimen	-
A	5-FU	-
A	leucovorin	-
B	leucovorin	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria	up to 4 years

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	up to 4 years
Response rate (complete response + partial response)	up to 4 years
Overall survival	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

Trial Locations

Locations (23)

Ingalls Cancer Research Center; 🇺🇸 Harvey, Illinois, United States

Toledo Comm. Onc. Program; 🇺🇸 Toledo, Ohio, United States

Virginia Cancer Institute; 🇺🇸 Richmond, Virginia, United States

Ingalls Memorial Hospital; Cancer Research Center; 🇺🇸 Harvey, Illinois, United States

Baptist Hospital East; 🇺🇸 Louisville, Kentucky, United States

Research Medical Center - Antibiotic Research Associates, Inc.; 🇺🇸 Kansas City, Missouri, United States

Saint Louis Cancer Care, LLP; 🇺🇸 Bridgeton, Missouri, United States

Florida Cancer Specialists; SCRI; 🇺🇸 Fort Myers, Florida, United States

SCRI Tennessee Oncology Chattanooga; 🇺🇸 Chattanooga, Tennessee, United States

Georgia Cancer Specialists - Northside; 🇺🇸 Atlanta, Georgia, United States

University of Chicago; Hematology/Oncology; 🇺🇸 Chicago, Illinois, United States

South Carolina Oncology Associates - SCRI; 🇺🇸 Columbia, South Carolina, United States

Spartanburg Regional Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

University of Oklahoma; Stephenson Oklahoma Canc Ctr; 🇺🇸 Oklahoma City, Oklahoma, United States

South Texas Oncology & Hematology, P.A.; 🇺🇸 San Antonio, Texas, United States

Tennessee Onc., PLLC - SCRI; 🇺🇸 Nashville, Tennessee, United States

Almac Clinical Technologies; 🇺🇸 San Francisco, California, United States

Oncology Hematology Care Inc; 🇺🇸 Cincinnati, Ohio, United States

Rocky Mountain Cancer Centers; Bone and Marrow Trans; 🇺🇸 Denver, Colorado, United States

Center For Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

Florida Hospital Cancer Inst; 🇺🇸 Orlando, Florida, United States

Hem-Onc Assoc of Northern NJ; 🇺🇸 Morristown, New Jersey, United States

Ctr for Cancer and Blood Disorders; 🇺🇸 Fort Worth, Texas, United States