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

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.

Conditions

• Head and Neck Cancer

Interventions

BIOLOGICAL

cetuximab

DRUG

carboplatin

DRUG

cisplatin

DRUG

docetaxel

DRUG

fluorouracil

GENETIC

fluorescence in situ hybridization

GENETIC

molecular genetic technique

GENETIC

reverse transcriptase-polymerase chain reaction

OTHER

immunoenzyme technique

OTHER

immunohistochemistry staining method

OTHER

laboratory biomarker analysis

PROCEDURE

biopsy

RADIATION

3-dimensional conformal radiation therapy

RADIATION

intensity-modulated radiation therapy

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• Jan B. Vermorken, MD, PhD · University Hospital, Antwerp

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2010-05-31

Completion

2011-04-30

Countries

• Belgium

Study Locations