NCT00665392

Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer

Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	75 mg/m², day 1. 3 cycles
DRUG	docetaxel	75 mg/m² Day 1. 3 cycles
DRUG	fluorouracil	750 mg/m² day 1 to day 5. 3 cycles
DRUG	Cetuximab	400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-02-01
• Completion: 2013-11-01
• First posted: 2008-04-23
• Last updated: 2025-08-01
• Results posted: 2021-06-25

Locations

8 sites across 1 country: France