Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Rectal Cancer

Colorectal Cancer Clinical Trial

Official title: Neoadjuvant Conformal Radiotherapy and Concomitant CPT-11 and EGFR Inhibition With Cetuximab in Patients With Rectal Cancer Phase I Study

Status Recruiting

Clinical Trial Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with cetuximab and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV rectal cancer.

Clinical Trial Description

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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

• NCT number: NCT00392470
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2006