Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer (ECHO-07)

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: Cetuximab

Drug: fluorouracil

Drug: cisplatin

Drug: docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00665392

CDR0000593027

MERCK-GERCOR-ECHO-07-1 (Other Identifier)

2007-002116-25 (EudraCT Number)

GERCOR-ECHO-07-1 (Other Identifier)

EU-20838 (Registry Identifier)

Details and patient eligibility

About

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. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.

Full description

OBJECTIVES:

Primary

To determine the complete clinical response rate at 3 months in patients with stage III or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab, docetaxel, cisplatin, and fluorouracil.

Secondary

To determine the rate of tumor response.
To determine progression-free and overall survival.
To determine the rate of complete pathological response.
To assess the tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for 1 year and every 3 months for 2 years.

Enrollment

42 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the oropharynx
- Stage III (T3 or T1-2, N1-2, M0) or nonmetastatic stage IV (T4 or T1-3, N3, M0) disease
- Resectable disease
Measurable or evaluable disease
Tumor tissue available

PATIENT CHARACTERISTICS:

Inclusion criteria:

WHO performance status 0-1
ANC ≥ 1,500/mm3
Platelet count ≥ 100,000/mm3
Hemoglobin ≥ 9 g/dL
Creatinine < 1.5 times upper limit of normal (ULN)
Creatinine clearance ≥ 60 mL/min
AST and ALT < 5 times ULN
Bilirubin < 1.5 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception
Affiliated with social security (including CMU)

Exclusion criteria:

Cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
Serious and/or uncontrolled cardiac or respiratory disease (pulmonary fibrosis, interstitial pneumopathy)
Other cancer within the past 5 years except for resected skin cancer, localized cutaneous or totally resected melanoma, or resected carcinoma in situ of the cervix
Auditory condition precluding the use of cisplatin
Contraindication due to psychological, social, or geographical reasons that may impede proper monitoring of treatment
Persons under guardianship or trusteeship, or prisoners of law

PRIOR CONCURRENT THERAPY: