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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
75 mg/m², day 1. 3 cycles
75 mg/m² Day 1. 3 cycles
750 mg/m² day 1 to day 5. 3 cycles
400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Hôpital Simone Veil
Montmorency, France
Hôpital Privé St Joseph
Paris, France
Hopital Europeen Georges Pompidou
Paris, France
Hopital Bichat - Claude Bernard
Paris, France
Hopital Tenon
Paris, France
centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre René Huguenin
Saint-Cloud, France
Hopital Foch
Suresnes, France
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months
The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination
Time frame: at 3 months after ETPF combination
Complete Clinical Response (cCR)
Clinical complete response (cCR) is defined by: * Disappearance of all clinical evidence of visible tumor, * Disappearance of all palpable residual infiltration, * Disappearance of all evidence of residual visible tumor on CT scan in pharynx and parapharyngeal space, * Complete symmetric remobilization of the tongue and amygdala. * Disappearance of pre-existing trismus. * Negative control biopsy. The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination
Time frame: at 3 months
The 2-year Estimated Overall Survival (OS) Rate
2-year OS measured survival at 2 years from randomization.
Time frame: 2 years
Pathologic Response
On primary tumor resected : measure of persistence or not of tumoral lesion, histological type, size and quality of the excision piece A pathological complete response is defined as no viable tumour cells detected on histological examination post surgery.
Time frame: after surgery of the primary tumor
The 2-year Estimated Progression-free Survival (PFS)
2-year PFS measured survival at 2 years from randomization.
Time frame: 2 years
Complete Radiological Response (rCR)
Radiological response is defined according to RECIST 1.0 criteria: * Complete response (CR): disappearance of all target lesions * Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, * Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target the appearance of one or more new lesions, * Stable disease (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started
Time frame: At 3 months after the end of 3 cycles of the ETPF combination
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