Cetuximab and Irinotecan in Treating Patients With Advanced Colorectal Cancer

Sponsor
University of Alabama at Birmingham
Study ID
NCT00005076
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of cetuximab and irinotecan in treating patients who have advanced colorectal cancer that has not responded to previous treatment.

Key Dates

Start date
Oct 31, 1999
Status verified
Apr 2013
Primary completion
Jul 31, 2005
Completion
Jul 31, 2005

Study Design

Enrollment
110 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EgFR antibody

Primary Outcome Measure

Determine the complete and partial response rates and time to progression in patients with refractory advanced colorectal carcinoma treated with cetuximab and irinotecan. [ Time Frame: baseline to 40 weeks ]

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