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Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Head and Neck Cancer

This study is not yet open for patient recruitment.

Sponsored by: Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving a monoclonal antibody with chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: Phase II trial to study the effectiveness of combining cetuximab with combination chemotherapy and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV head and neck cancer.

Condition Treatment or Intervention Phase
Hypopharyngeal Cancer
Laryngeal Cancer
lip and oral cavity cancer
Oropharyngeal Cancer
paranasal sinus and nasal cavity cancer
Salivary Gland Cancer
 Drug: carboplatin
 Drug: cetuximab
 Drug: paclitaxel
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemosensitization/potentiation
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: monoclonal antibody therapy
 Procedure: neoadjuvant therapy
 Procedure: radiation therapy
 Procedure: radiosensitization
 Procedure: surgery
Phase II

MedlinePlus related topics:  Head and Neck Cancer;   Nasal Cancer;   Oral Cancer;   Salivary Gland Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Neoadjuvant Induction Therapy Comprising Cetuximab, Paclitaxel, and Carboplatin Followed By Chemoradiotherapy Comprising Cetuximab, Paclitaxel, Carboplatin, and Radiotherapy in Patients With Stage III or IV Operable Squamous Cell Cancer of the Head and Neck

Further Study Details: 

OBJECTIVES: Primary

Secondary

OUTLINE: This is a multicenter study.

Patients with a positive biopsy at week 7 or 8 or persistent tumor at the primary site after induction therapy undergo a second biopsy on week 14. Patients with a negative biopsy at week 14 receive additional chemoradiotherapy (as outlined above) on weeks 14-16. Patients with N1-N3 disease undergo neck dissection on weeks 20-21. Patients with a positive biopsy at week 14 do not receive additional chemoradiotherapy, but rather undergo surgical resection of the primary site on weeks 18-19. Patients with N1-N3 disease also undergo neck dissection at this time.

Quality of life is assessed at baseline, at weeks 7 or 8, 14, and 20 during study treatment, and then at 3, 6, and 12 months after completion of study treatment.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 years.

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

Performance status

Life expectancy

Hematopoietic

Hepatic

Renal

Cardiovascular

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

Surgery

Other


Location Information


Study chairs or principal investigators

Harold J. Wanebo, MD,  Study Chair,  Roger Williams Medical Center   
Barbara A. Burtness, MD,  Yale Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000378194; ECOG-E2303
Record last reviewed:  August 2004
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00089297
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20
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