Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer That Cannot Be Removed By Surgery

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: 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. Cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high energy x- rays to kill tumor cells. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of radiation therapy, combination chemotherapy, and cetuximab and is most effective in treating patients with head and neck cancer.

PURPOSE: This randomized phase II trial is comparing two different regimens of radiation therapy given together with combination chemotherapy and cetuximab to see how well they work in treating patients with newly diagnosed stage III or stage IV head and neck cancer that cannot be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Carboplatin; Cetuximab; Docetaxel; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed squamous cell carcinoma of the head and neck

• Stage III or IV disease

• Unresectable disease

• Unidimensionally or bidimensionally measurable disease

• Skin and tumor material must be available for EGFR status and downstream signaling studies

• No nasopharyngeal, nasal, or paranasal cancer

• No distant metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 1.5 times the upper limit of normal (ULN)

• Alkaline phosphatase and transaminases ≤ 2.5 times ULN

• Serum creatinine ≤ 120 μmol/L (1.36 mg/dL)

• Creatinine clearance ≥ 60 mL/min

• Normal cardiac function (i.e., LVEF ≥ 50%)

• Clinically satisfactory 12-lead ECG

• No serious cardiac illness or medical condition within the past 6 months

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No current malignancies at other sites with the exception of cone-biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which the patient has been disease-free for at least the past five years

• No unstable systemic diseases

• No active uncontrolled infections

• No psychological, familial, sociological, or geographical condition that would preclude compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior treatment for head and neck cancer

• No other concurrent anticancer therapy

• No other concurrent investigational agents