Status:
COMPLETED
Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 c...
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, do...
Eligibility Criteria
Inclusion
- 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/mm3
- Platelet count ≥ 100,000/mm3
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00665392
Start Date
February 1 2008
End Date
November 1 2013
Last Update
August 1 2025
Active Locations (8)
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1
Hôpital Simone Veil
Montmorency, France, 95160
2
Hôpital Privé St Joseph
Paris, France, 75014
3
Hopital Europeen Georges Pompidou
Paris, France, 75015
4
Hopital Bichat - Claude Bernard
Paris, France, 75018