FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Genentech
Collaborator:
Sarah Cannon Research Institute
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01418222
First received: August 15, 2011
Last updated: March 19, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: onartuzumab [MetMAb] Drug: Placebo Drug: bevacizumab [Avastin] Drug: FOLFOX regimen Drug: leucovorin Drug: 5-FU |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate (complete response + partial response) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
| Enrollment: | 196 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: onartuzumab [MetMAb]
Intravenous repeating dose
Drug: bevacizumab [Avastin]
Intravenous repeating dose
Drug: FOLFOX regimen
Intravenous repeating dose
Drug: leucovorin
Intravenous repeating dose
Drug: 5-FU
Intravenous repeating dose
|
| Active Comparator: B |
Drug: Placebo
Intravenous repeating dose
Drug: bevacizumab [Avastin]
Intravenous repeating dose
Drug: FOLFOX regimen
Intravenous repeating dose
Drug: leucovorin
Intravenous repeating dose
Drug: 5-FU
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418222
Hide Study Locations
Hide Study LocationsLocations
| United States, California | |
| San Francisco, California, United States, 94105 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| New Haven, Connecticut, United States, 06510-3289 | |
| United States, Florida | |
| Fort Myers, Florida, United States, 33916 | |
| Orlando, Florida, United States, 32904 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| Harvey, Illinois, United States, 60426 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Maryland | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Missouri | |
| Bridgeton, Missouri, United States, 63044 | |
| Kansas City, Missouri, United States, 64132 | |
| United States, New Jersey | |
| Morristown, New Jersey, United States, 07962 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45242 | |
| Toledo, Ohio, United States, 43617 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, South Carolina | |
| Columbia, South Carolina, United States, 29210 | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Chattanooga, Tennessee, United States, 37404 | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Fort Worth, Texas, United States, 76104 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23230 | |
Sponsors and Collaborators
Genentech
Sarah Cannon Research Institute
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01418222 History of Changes |
| Other Study ID Numbers: | GO27827 |
| Study First Received: | August 15, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
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 Levoleucovorin |
Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013