Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF)for Squamous Cell Carcinoma of the Oropharynx That is Operable Stage III-IV
18 Years
75 Years
Both
Head and Neck Cancer
Trial Information
Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF)for Squamous Cell Carcinoma of the Oropharynx That is Operable Stage III-IV
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.
Inclusion 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/mm^3
- Platelet count ≥ 100,000/mm^3
- 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:
- No prior treatment, including chemotherapy or radiotherapy
- No concurrent phenytoin, live attenuated vaccines, or parenteral aminoglycosides
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete clinical response rate at 3 months
Outcome Time Frame:
at 3 months
Safety Issue:
No
Principal Investigator
Jean Lacau Saint Guily, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hopital Tenon
Authority:
France: Committee of the Protection of the Persons
Study ID:
CDR0000593027
NCT ID:
NCT00665392
Start Date:
February 2008
Completion Date:
July 2012
Related Keywords:
- Head and Neck Cancer
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- tongue cancer
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Oropharyngeal Neoplasms
Name | Location |
|---|
