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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Vaudois
• Treatments: Cetuximab; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the rectum

• T3-4 and/or N+ (stage IIIB, IIIC, or IV disease)

• Liver or lung metastasis allowed

• No recurrent disease

PATIENT CHARACTERISTICS:

• WHO performance status 0 or 1

• Hematologic, liver, and renal function normal

• Considered fit for chemotherapy, radiotherapy, and surgery

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No symptomatic heart disease or myocardial infarction during the past 6 months

• No chronic inflammatory bowel disease

• No malignant tumor during the past 5 years except for completely surgically resected carcinoma of the cervix or squamous cell carcinoma of the skin

• No other concurrent malignant tumor

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for rectal cancer

• No prior radiotherapy to the pelvis