OBJECTIVES:
Primary
* Determine the toxicity of irinotecan hydrochloride and cetuximab in patients with stage III or IV rectal cancer undergoing conformal or intensity-modulated radiotherapy.
Secondary
* Determine the rate of pathologic response and histological degree of tumor regression in patients treated with this regimen.
* Determine the complete resection rate (R0) in patients treated with this regimen.
* Determine the sphincter preservation rate in patients treated with this regimen.
* Determine the 30-day postoperative complication rate in patients treated with this regimen.
* Determine the local and distant relapse rate and site of disease failure in patients treated with this regimen.
* Estimate the predictive value of fludeoxyglucose F 18 positron emission tomography/CT scan for treatment response compared to endoscopic ultrasonography (EUS), CT scan, and MRI in patients treated with this regimen.
* Determine the late toxicity of this regimen in these patients.
* Determine the clinical (radiological) tumor response (i.e., MRI, CT scan, EUS) in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of irinotecan hydrochloride.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43 followed by irinotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, and 29. Patients also undergo conformal radiotherapy or intensity-modulated radiotherapy on days 1-5 for 5 weeks. Patients undergo radical surgery 3-4 weeks after completion of neoadjuvant therapy.
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
