Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx
Eligibility Criteria
Inclusion Criteria: Histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck (excluding nasopharynx, paranasal sinus, and parotid gland) Unresectable locally advanced or regional stage IV disease No evidence of distant metastases Must have demonstrable primary tumor site Measurable disease Unresectable disease Meets the following criteria for unresectable disease by tumor site: Hypopharynx, meeting 1 of the following criteria: Extension across the midline of the posterior pharyngeal wall Any evidence of fixation to the cervical spine Larynx Direct subglottic extension (>3cm) into surrounding muscle or skin Oral cavity Lesion precluding functional reconstruction Base of tongue, meeting 1 of the following criteria: Extension into the root of the tongue Patient refuses total glossectomy Tonsillar area, meeting 1 of the following criteria: Extension into pterygoid area as manifested by x-ray or trismus Extension across midline of pharyngeal wall Direct extension into soft tissue of the neck Unilateral neck node metastases fixed to carotid artery, mastoid, base of skull, or cervical spine with any of the above tumors Patients requiring total glossectomy are eligible Age>=18 years ECOG Performance status of 0-1 Adequate hematologic, renal, and hepatic function obtained <=4 weeks prior to registration Absolute neutrophil count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL Alkaline phosphatase ≤ 3 times normal Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 3 times normal Bilirubin ≤ 1.5 mg/dL Creatinine ≤ 1.2 mg/dL OR creatinine clearance ≥ 50 mL/min Able to tolerate fluid load At least 14 days since major surgery (including dental extraction) except percutaneous endoscopic gastrostomy (PEG) placement or mediport placement Exclusion Criteria: Pregnant or nursing Fertile patients do not use effective contraception Patients who refuse surgery but whose tumors are technically resectable OR whose tumors are unresectable for medical reasons are not eligible Disease metastases below the clavicles or elsewhere (M1) or with a postoperative recurrence Prior excisional surgery of head and neck tumor Prior radiotherapy to the head and neck region Prior chemotherapy Prior drugs that target the epidermal growth factor receptor pathway Prior chimerized or murine monoclonal antibody Active systemic infection Known allergy to murine proteins Severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year Myocardial infarction within the past 3 months Uncontrolled congestive heart failure Unstable or uncontrolled angina Clinically apparent jaundice Postoperative recurrence Other malignancy within the past 3 years except resected basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ tumors
Sites / Locations
Arms of the Study
Arm 1
Experimental
Cisplatin, C225, Radiation
Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57. Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57. Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.