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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418222
• Other study ID #: GO27827
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2011
• Last updated: May 25, 2017
• Start date: September 14, 2011
• Est. completion date: March 18, 2013

Study information

• Verified date: May 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: March 18, 2013
• Est. primary completion date: March 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 5-FU
Intravenous repeating dose
• FOLFOX regimen
Intravenous repeating dose
• Placebo
Intravenous repeating dose
• bevacizumab [Avastin]
Intravenous repeating dose
• leucovorin
Intravenous repeating dose
• onartuzumab [MetMAb]
Intravenous repeating dose

Locations

Country	Name	City	State
United States	Georgia Cancer Specialists - Northside	Atlanta	Georgia
United States	Center For Cancer and Blood Disorders	Bethesda	Maryland
United States	Saint Louis Cancer Care, LLP	Bridgeton	Missouri
United States	SCRI Tennessee Oncology Chattanooga	Chattanooga	Tennessee
United States	University of Chicago; Hematology/Oncology	Chicago	Illinois
United States	Oncology Hematology Care Inc	Cincinnati	Ohio
United States	South Carolina Oncology Associates - SCRI	Columbia	South Carolina
United States	Rocky Mountain Cancer Centers; Bone and Marrow Trans	Denver	Colorado
United States	Florida Cancer Specialists; SCRI	Fort Myers	Florida
United States	Ctr for Cancer and Blood Disorders	Fort Worth	Texas
United States	Ingalls Cancer Research Center	Harvey	Illinois
United States	Ingalls Memorial Hospital; Cancer Research Center	Harvey	Illinois
United States	Research Medical Center - Antibiotic Research Associates, Inc.	Kansas City	Missouri
United States	Baptist Hospital East	Louisville	Kentucky
United States	Hem-Onc Assoc of Northern NJ	Morristown	New Jersey
United States	Tennessee Onc., PLLC - SCRI	Nashville	Tennessee
United States	University of Oklahoma; Stephenson Oklahoma Canc Ctr	Oklahoma City	Oklahoma
United States	Florida Hospital Cancer Inst	Orlando	Florida
United States	Virginia Cancer Institute	Richmond	Virginia
United States	South Texas Oncology & Hematology, P.A.	San Antonio	Texas
United States	Almac Clinical Technologies	San Francisco	California
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Toledo Comm. Onc. Program	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	SCRI Development Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria		up to 4 years
Secondary	Response rate (complete response + partial response)		up to 4 years
Secondary	Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death		up to 4 years
Secondary	Overall survival		up to 4 years
Secondary	Safety: Incidence of adverse events		up to 4 years