Phase II Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Chemotherapy in Patients With Advanced Colorectal Carcinoma
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the complete and partial response rates and time to progression in patients with refractory advanced colorectal carcinoma treated with cetuximab and irinotecan.
baseline to 40 weeks
Albert F. LoBuglio, MD
University of Alabama at Birmingham
United States: Federal Government