Status:
TERMINATED
Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
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: * To determine the safety profile of chemoradiotherapy with carboplatin vs cisplatin in patients with newly diagnosed, unresectable stage III or IV squamous cell carcinoma of the head and...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed squamous cell carcinoma of the head and neck
- Stage III or IV disease
- Unresectable disease
- Unidimensionally or bidimensionally measurable disease
- Skin and tumor material must be available for EGFR status and downstream signaling studies
- No nasopharyngeal, nasal, or paranasal cancer
- No distant metastases
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- Alkaline phosphatase and transaminases ≤ 2.5 times ULN
- Serum creatinine ≤ 120 μmol/L (1.36 mg/dL)
- Creatinine clearance ≥ 60 mL/min
- Normal cardiac function (i.e., LVEF ≥ 50%)
- Clinically satisfactory 12-lead ECG
- No serious cardiac illness or medical condition within the past 6 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No current malignancies at other sites with the exception of cone-biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which the patient has been disease-free for at least the past five years
- No unstable systemic diseases
- No active uncontrolled infections
- No psychological, familial, sociological, or geographical condition that would preclude compliance with the study protocol and follow-up schedule
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment for head and neck cancer
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00646659
Start Date
February 1 2008
End Date
April 1 2011
Last Update
July 9 2018
Active Locations (1)
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1
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650