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Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer

Information source: ImClone LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: cetuximab (Biological); oxaliplatin (Drug); leucovorin (Drug); 5-fluorouracil (Drug); 5-fluorouracil (Drug); cetuximab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: ImClone LLC

Official(s) and/or principal investigator(s):
E-mail: ClinicalTrials@ ImClone.com, Study Chair, Affiliation: ImClone LLC

Summary

The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.

Clinical Details

Official title: A Phase 3 Randomized Multicenter Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in Subjects With Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone.

Secondary outcome:

Compare the response rates between the two treatment arms.

Compare progression-free survival between the two treatment arms.

Duration of response within each treatment arm.

Time to response within each treatment arm.

Compare the safety profiles between the two treatment arms.

Compare the quality of life (QOL)between the two treatment arms.

Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Documented colorectal cancer which is EGFR-positive and is metastatic.

- Prior irinotecan, alone or in combination, as first-line treatment of metastatic

disease. Exclusion Criteria:

- A serious uncontrolled medical disorder that, in the opinion of the Investigator,

would impair the ability of the subject to receive protocol therapy.

- Known dihydropyrimidine dehydrogenase (DPD) deficiency.

- Known metastases in the central nervous system.

- Symptomatic sensory or peripheral neuropathy.

- More than one prior chemotherapy regimen for the treatment of metastatic colorectal

cancer.

- Prior oxaliplatin therapy.

- Prior cetuximab or other therapy which targets the EGF pathway.

- Prior chimerized or murine monoclonal antibody therapy.

Locations and Contacts

ImClone Investigational Site, Little Rock, Arkansas 72205, United States

ImClone Investigational Site, Springdale, Arkansas 72764, United States

ImClone Investigational Site, Fountain Valley, California 92708, United States

ImClone Investigational Site, Gilroy, California 95020, United States

ImClone Investigational Site, Greenbrae, California 94904, United States

ImClone Investigational Site, Orange, California 92868, United States

ImClone Investigational Site, Pomona, California 91767, United States

ImClone Investigational Site, San Diego, California 92120, United States

ImClone Investigational Site, Vista, California 92083, United States

ImClone Investigational Site, Hartford, Connecticut 06105, United States

ImClone Investigational Site, Norwalk, Connecticut 06856, United States

ImClone Investigational Site, Stamford, Connecticut 06902, United States

ImClone Investigational Site, Waterbury, Connecticut 06708, United States

ImClone Investigational Site, Boynton Beach, Florida 33435, United States

ImClone Investigational Site, Jacksonville, Florida 32207, United States

ImClone Investigational Site, Leesburg, Florida 34748, United States

ImClone Investigational Site, Orlando, Florida 32804, United States

ImClone Investigational Site, Tampa, Florida 33613, United States

ImClone Investigational Site, Atlanta, Georgia 30309, United States

ImClone Investigational Site, Macon, Georgia 31201, United States

ImClone Investigational Site, Louisville, Kentucky 40202, United States

ImClone Investigational Site, Baton Rouge, Louisiana 70809, United States

ImClone Investigational Site, Baltimore, Maryland 21225, United States

ImClone Investigational Site, Clinton, Maryland 20735, United States

ImClone Investigational Site, St. Joseph, Michigan 49085, United States

ImClone Investigational Site, Kansas City, Missouri 64131, United States

ImClone Investigational Site, Rolla, Missouri 65401, United States

ImClone Investigational Site, Hackensack, New Jersey 07601, United States

ImClone Investigational Site, Armonk, New York 10504, United States

ImClone Investigational Site, Brooklyn, New York 11235, United States

ImClone Investigational Site, East Setauket, New York 11733, United States

ImClone Investigational Site, Winston-Salem, North Carolina 27103, United States

ImClone Investigational Site, Bismarck, North Dakota 58501, United States

ImClone Investigational Site, Philadelphia, Pennsylvania 19107, United States

ImClone Investigational Site, Charleston, South Carolina 29406, United States

ImClone Investigational Site, Knoxville, Tennessee 37920, United States

ImClone Investigational Site, Nashville, Tennessee 37203, United States

ImClone Investigational Site, Ogden, Utah 84403, United States

ImClone Investigational Site, Richmond, Virginia 23230, United States

Additional Information

Starting date: March 2003
Last updated: April 8, 2010

Page last updated: August 20, 2015

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