Cetuximab and Irinotecan in Treating Patients With Advanced Colorectal Cancer
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.
|Colorectal Cancer||Biological: cetuximab Drug: irinotecan hydrochloride||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Chemotherapy in Patients With Advanced Colorectal Carcinoma|
- 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 ]
- Determine the safety and toxicity profile of this regimen in these patients. [ Time Frame: baseline to 40 weeks ]
- Assess the quality of life of patients treated with this regimen. [ Time Frame: baseline to 40 weeks ]
- Determine the tumor epidermal growth factor receptor levels in patients treated with this regimen [ Time Frame: baseline to 40 weeks ]
|Study Start Date:||October 1999|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
|Experimental: EgFR antibody||Biological: cetuximab Drug: irinotecan hydrochloride|
OBJECTIVES: I. Determine the complete and partial response rates and time to progression in patients with refractory advanced colorectal carcinoma treated with cetuximab and irinotecan. II. Determine the safety and toxicity profile of this regimen in these patients. III. Assess the quality of life of patients treated with this regimen. IV. Determine the tumor epidermal growth factor receptor levels in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by response to irinotecan based chemotherapy regimen (stable disease vs disease progression). Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive maintenance cetuximab IV over 1 hour on days 8, 15, 22, 29, and 36. Patients receive irinotecan IV over 90 minutes (beginning 1 hour after completion of cetuximab infusion) at the same regimen (dosage and frequency) on which the patient became refractory to irinotecan therapy. Irinotecan is administered at a higher dose on days 1 and 22 OR at a lower dose on days 1, 8, 15, and 22. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with unacceptable toxicity to irinotecan may continue on cetuximab maintenance therapy alone at the discretion of the protocol investigator and sponsor. Quality of life is assessed before initiation of study therapy, at the completion of each course, and then at 4 weeks after completion of study. Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 110 patients (55 per strata) will be accrued for this study within 7 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005076
|Study Chair:||Albert F. LoBuglio, MD||University of Alabama at Birmingham|