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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 SiteGreenwich, Connecticut  06830
ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteSt. Charles, Missouri  63301
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteLouisville, Kentucky  40202
ImClone Investigational SiteNew Orleans, Louisiana  70121
ImClone Investigational SiteBaltimore, Maryland  21204
ImClone Investigational SiteYpsilanti, Michigan  48198
ImClone Investigational SiteVoorhees, New Jersey  08043
ImClone Investigational SiteGreenville, South Carolina  29605
ImClone Investigational SiteMemphis, Tennessee  38104
ImClone Investigational SiteNorfolk, Virginia  23502
ImClone Investigational SiteLittle Rock, Arkansas  72205
ImClone Investigational SiteWinston-Salem, North Carolina  27103
ImClone Investigational SiteBismarck, North Dakota  58501
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteOgden, Utah  84403