Clinical trial NCT00061815: Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2003-06-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: Every six weeks
Secondary outcomes:
measure: Compare the response rates between the two treatment arms.
timeFrame: Every six weeks
measure: Compare progression-free survival between the two treatment arms.
timeFrame: Every six weeks
measure: Duration of response within each treatment arm.
timeFrame: Every six weeks
measure: Time to response within each treatment arm.
timeFrame: Every six weeks
measure: Compare the safety profiles between the two treatment arms.
timeFrame: Every six weeks
measure: Compare the quality of life (QOL)between the two treatment arms.
timeFrame: Every six weeks
measure: Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.
timeFrame: Every six weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: ImClone Investigational Site
state: Arkansas
city: Springdale
country: United States
facility: ImClone Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: ImClone Investigational Site
state: California
city: Gilroy
country: United States
facility: ImClone Investigational Site
state: California
city: Greenbrae
country: United States
facility: ImClone Investigational Site
state: California
city: Orange
country: United States
facility: ImClone Investigational Site
state: California
city: Pomona
country: United States
facility: ImClone Investigational Site
state: California
city: San Diego
country: United States
facility: ImClone Investigational Site
state: California
city: Vista
country: United States
facility: ImClone Investigational Site
state: California
city: Hartford
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: Norwalk
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: Stamford
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: ImClone Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: ImClone Investigational Site
state: Florida
city: Leesburg
country: United States
facility: ImClone Investigational Site
state: Florida
city: Orlando
country: United States
facility: ImClone Investigational Site
state: Florida
city: Tampa
country: United States
facility: ImClone Investigational Site
state: Florida
city: Atlanta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Macon
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Louisville
country: United States
facility: ImClone Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: ImClone Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: ImClone Investigational Site
state: Maryland
city: Clinton
country: United States
facility: ImClone Investigational Site
state: Maryland
city: St. Joseph
country: United States
facility: ImClone Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: ImClone Investigational Site
state: Missouri
city: Rolla
country: United States
facility: ImClone Investigational Site
state: Missouri
city: Hackensack
country: United States
facility: ImClone Investigational Site
state: New Jersey
city: Armonk
country: United States
facility: ImClone Investigational Site
state: New York
city: Brooklyn
country: United States
facility: ImClone Investigational Site
state: New York
city: East Setauket
country: United States
facility: ImClone Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: ImClone Investigational Site
state: North Dakota
city: Philadelphia
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: ImClone Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Ogden
country: United States
facility: ImClone Investigational Site
state: Utah
city: Richmond
country: United States
facility: ImClone Investigational Site
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: E-mail: ClinicalTrials@ ImClone.com
role: STUDY_CHAIR
References: