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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

Every six weeks

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

CA225-014

NCT ID:

NCT00061815

Start Date:

March 2003

Completion Date:

November 2005

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

ImClone Investigational Site Greenwich, Connecticut  06830
ImClone Investigational Site New York, New York  10021
ImClone Investigational Site St. Charles, Missouri  63301
ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Jacksonville, Florida  32207
ImClone Investigational Site Atlanta, Georgia  30318
ImClone Investigational Site Louisville, Kentucky  40202
ImClone Investigational Site New Orleans, Louisiana  70121
ImClone Investigational Site Baltimore, Maryland  21204
ImClone Investigational Site Ypsilanti, Michigan  48198
ImClone Investigational Site Voorhees, New Jersey  08043
ImClone Investigational Site Greenville, South Carolina  29605
ImClone Investigational Site Memphis, Tennessee  38104
ImClone Investigational Site Norfolk, Virginia  23502
ImClone Investigational Site Little Rock, Arkansas  72205
ImClone Investigational Site Winston-Salem, North Carolina  27103
ImClone Investigational Site Bismarck, North Dakota  58501
ImClone Investigational Site Philadelphia, Pennsylvania  19107
ImClone Investigational Site Ogden, Utah  84403