Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer (AACER)

Centre Antoine Lacassagne

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Biological: cetuximab

Radiation: radiation therapy

Drug: cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00875849

2007/23

MERCK-CALACASS-AACER

2007-004384-22 (EudraCT Number)

INCA-RECF0623

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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 chemotherapy together with radiation therapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.

Full description

OBJECTIVES:

Primary

Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after complete surgical resection.

Secondary

Evaluate quality of life.
Evaluate tolerability.
Evaluate overall survival.
Analyze germinal polymorphisms.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on day 1. Treatment with cetuximab repeats every week for up to 8 courses. Patients also receive cisplatin IV on day 8. Treatment with cisplatin repeats every 3 weeks for up to 3 courses. Patients undergo concurrent radiotherapy 5 times a week for 7 weeks beginning on day 8.

After completion of study treatment, patients are followed at 1 month and then every 3 months for 2 years.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Must have undergone complete macroscopic resection
Presence of ≥ 1 of the following poor prognostic factors after complete resection:
- Incomplete microscopic resection and N+
- Complete microscopic resection and > 2 N+
- Vascular and/or lymphatic embolism
- At least 2 peripheral nerve invasions
- Positive surgical margins and pT4 lesion
No metastases

PATIENT CHARACTERISTICS:

WHO performance status 0-2
ANC > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin > 9 g/dL
Bilirubin < 1.5 times upper limit of normal (ULN)
Serum creatinine < 1.25 times ULN and/or creatinine clearance > 55 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception
No serious and disabling cardiac, renal, hepatic, or respiratory failure
No coronary artery disease or myocardial infarction within the past year
No uncontrolled cardiac arrhythmia
Other active and serious diseases allowed at discretion of the investigator
No known severe allergy to cisplatin, cetuximab, or any of their excipients
No other malignant disease diagnosed within the past 5 years except for basal cell carcinoma of the skin or in situ cervical cancer
No psychological, familial, social, or geographic situations that preclude clinical follow up

PRIOR CONCURRENT THERAPY:

No prior treatment (except surgery) for this cancer or another head and neck cancer
At least 3 months since prior treatment with an investigational agent