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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Genentech, Inc.
SCRI Development Innovations, LLC
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01418222    
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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Bevacizumab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients