Cetuximab and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Oropharynx Cancer That Can Be Removed by Surgery
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.
Head and Neck Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF)for Squamous Cell Carcinoma of the Oropharynx That is Operable Stage III-IV|
- Complete clinical response rate at 3 months [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
- Rate of response (partial and complete response and stable disease) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: from inclusion to first disease progression with chemotherapy ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From inclusion to patient's decease ] [ Designated as safety issue: No ]
- Pathologic response [ Time Frame: after surgery of the primary tumor ] [ Designated as safety issue: No ]On primary tumor resected : measure of persistence or not of tumoral lesion, histological type, size and quality of the excision piece
- Tolerability [ Time Frame: until 1 month after the last administration ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
75 mg/m², day 1. 3 cyclesDrug: docetaxel
75 mg/m² Day 1. 3 cyclesDrug: fluorouracil
750 mg/m² day 1 to day 5. 3 cyclesDrug: Cetuximab
400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665392
|Hôpital Simone Veil|
|Montmorency, France, 95160|
|Hôpital Privé St Joseph|
|Paris, France, 75014|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Paris, France, 75970|
|centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Centre René Huguenin|
|Saint Cloud, France, 92100|
|Suresnes, France, 92151|
|Principal Investigator:||Jean Lacau Saint Guily, MD||Hopital Tenon|