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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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ClinicalTrials.gov Identifier: NCT01418222
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: 5-FU Drug: FOLFOX regimen Drug: Placebo Drug: bevacizumab [Avastin] Drug: leucovorin Drug: onartuzumab [MetMAb] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 14, 2011
Actual Primary Completion Date : March 18, 2013
Actual Study Completion Date : March 18, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: A Drug: 5-FU
Intravenous repeating dose

Drug: FOLFOX regimen
Intravenous repeating dose

Drug: bevacizumab [Avastin]
Intravenous repeating dose

Drug: leucovorin
Intravenous repeating dose

Drug: onartuzumab [MetMAb]
Intravenous repeating dose

Active Comparator: B Drug: 5-FU
Intravenous repeating dose

Drug: FOLFOX regimen
Intravenous repeating dose

Drug: Placebo
Intravenous repeating dose

Drug: bevacizumab [Avastin]
Intravenous repeating dose

Drug: leucovorin
Intravenous repeating dose




Primary Outcome Measures :
  1. 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 Measures :
  1. Response rate (complete response + partial response) [ Time Frame: up to 4 years ]
  2. 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 ]
  3. Overall survival [ Time Frame: up to 4 years ]
  4. Safety: Incidence of adverse events [ Time Frame: up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418222


  Hide Study Locations
Locations
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United States, California
Almac Clinical Technologies
San Francisco, California, United States, 94105
United States, Colorado
Rocky Mountain Cancer Centers; Bone and Marrow Trans
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States, 33901
Florida Hospital Cancer Inst
Orlando, Florida, United States, 32804
United States, Georgia
Georgia Cancer Specialists - Northside
Atlanta, Georgia, United States, 30341
United States, Illinois
University of Chicago; Hematology/Oncology
Chicago, Illinois, United States, 60637
Ingalls Cancer Research Center
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital; Cancer Research Center
Harvey, Illinois, United States, 60426
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
United States, Maryland
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Missouri
Saint Louis Cancer Care, LLP
Bridgeton, Missouri, United States, 63044
Research Medical Center - Antibiotic Research Associates, Inc.
Kansas City, Missouri, United States, 64132
United States, New Jersey
Hem-Onc Assoc of Northern NJ
Morristown, New Jersey, United States, 07960
United States, Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
Toledo Comm. Onc. Program
Toledo, Ohio, United States, 43623
United States, Oklahoma
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, United States, 29210
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States, 37404
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, United States, 37203
United States, Texas
Ctr for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
South Texas Oncology & Hematology, P.A.
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Genentech, Inc.
SCRI Development Innovations, LLC
Investigators
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Study Director: Clinical Trials Genentech, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01418222     History of Changes
Other Study ID Numbers: GO27827
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors