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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061815
• Other study ID #: CA225-014
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2003
• Last updated: April 8, 2010
• Start date: March 2003
• Est. completion date: November 2005

Study information

• Verified date: April 2010
• Source: ImClone LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00065520

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• cetuximab
400 mg/m2 IV

Drug:
• oxaliplatin
85 mg/m2 IV
• leucovorin
200 mg/m2 IV
• 5-fluorouracil
400 mg/m2 IV
• 5-fluorouracil
600 mg/m2 IV

Biological:
• cetuximab
250 mg/m2 IV

Locations

Country	Name	City	State
United States	ImClone Investigational Site	Armonk	New York
United States	ImClone Investigational Site	Atlanta	Georgia
United States	ImClone Investigational Site	Baltimore	Maryland
United States	ImClone Investigational Site	Baton Rouge	Louisiana
United States	ImClone Investigational Site	Bismarck	North Dakota
United States	ImClone Investigational Site	Boynton Beach	Florida
United States	ImClone Investigational Site	Brooklyn	New York
United States	ImClone Investigational Site	Charleston	South Carolina
United States	ImClone Investigational Site	Clinton	Maryland
United States	ImClone Investigational Site	East Setauket	New York
United States	ImClone Investigational Site	Fountain Valley	California
United States	ImClone Investigational Site	Gilroy	California
United States	ImClone Investigational Site	Greenbrae	California
United States	ImClone Investigational Site	Hackensack	New Jersey
United States	ImClone Investigational Site	Hartford	Connecticut
United States	ImClone Investigational Site	Jacksonville	Florida
United States	ImClone Investigational Site	Kansas City	Missouri
United States	ImClone Investigational Site	Knoxville	Tennessee
United States	ImClone Investigational Site	Leesburg	Florida
United States	ImClone Investigational Site	Little Rock	Arkansas
United States	ImClone Investigational Site	Louisville	Kentucky
United States	ImClone Investigational Site	Macon	Georgia
United States	ImClone Investigational Site	Nashville	Tennessee
United States	ImClone Investigational Site	Norwalk	Connecticut
United States	ImClone Investigational Site	Ogden	Utah
United States	ImClone Investigational Site	Orange	California
United States	ImClone Investigational Site	Orlando	Florida
United States	ImClone Investigational Site	Philadelphia	Pennsylvania
United States	ImClone Investigational Site	Pomona	California
United States	ImClone Investigational Site	Richmond	Virginia
United States	ImClone Investigational Site	Rolla	Missouri
United States	ImClone Investigational Site	San Diego	California
United States	ImClone Investigational Site	Springdale	Arkansas
United States	ImClone Investigational Site	St. Joseph	Michigan
United States	ImClone Investigational Site	Stamford	Connecticut
United States	ImClone Investigational Site	Tampa	Florida
United States	ImClone Investigational Site	Vista	California
United States	ImClone Investigational Site	Waterbury	Connecticut
United States	ImClone Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
ImClone LLC	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Every six weeks	No
Secondary	Compare the response rates between the two treatment arms.		Every six weeks	No
Secondary	Compare progression-free survival between the two treatment arms.		Every six weeks	No
Secondary	Duration of response within each treatment arm.		Every six weeks	No
Secondary	Time to response within each treatment arm.		Every six weeks	No
Secondary	Compare the safety profiles between the two treatment arms.		Every six weeks	Yes
Secondary	Compare the quality of life (QOL)between the two treatment arms.		Every six weeks	No
Secondary	Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.		Every six weeks	No