Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Mar 15, 2004

Keywords

ClinConnect Summary

OBJECTIVES: I. Determine the response rate, duration of response, and survival in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with cetuximab and cisplatin after failure of an initial cisplatin-based chemotherapy regimen. II. Determine the efficacy, safety, and toxicity of this regimen in these patients. III. Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study. Part I (courses 1 and 2): Patients are assigned to 1 of 2 treatment groups based on prior cisplatin-based chemotherapy regimen: Group 1...

Gender

ALL

Eligibility criteria

• • DISEASE CHARACTERISTICS: Histologically proven metastatic or recurrent squamous cell carcinoma of the head and neck Failure to respond to initial treatment with cisplatin and paclitaxel or cisplatin and fluorouracil Bidimensionally measurable disease Sufficient tumor tissue available for immunohistochemical determination of epidermal growth factor receptor expression No meningeal or CNS involvement by tumor
• • PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 WBC at least 3,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN AST and ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities Neurologic: No uncontrolled seizure disorder No active neurologic disease No neuropathy greater than grade 1 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix
• • PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy or cetuximab Chemotherapy: See Disease Characteristics More than 1 year since prior chemotherapy and recovered Cumulative total dose of prior platinum therapy no greater than 200 mg/m2 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 2 months since prior radiotherapy (1 month if disease progression occurred during radiotherapy) No concurrent radiotherapy Surgery: At least 2 months since prior surgery except diagnostic biopsy Other: At least 1 month since prior investigational agent