Conditions: Head and Neck Cancer
Keywords: stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx tongue cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

Brief 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. 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.

Detailed 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.

Arms:
arm 1: Cetuximab by intravenous (IV) infusion over 1-2 h on day

Interventions: intervention 1: cisplatin intervention 2: docetaxel intervention 3: fluorouracil intervention 4: Cetuximab
Intervention descriptions: intervention 1: 75 mg/m², day 1. 3 cycles intervention 2: 75 mg/m² Day 1. 3 cycles intervention 3: 750 mg/m² day 1 to day 5. 3 cycles intervention 4: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.

Protocol document: