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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cetuximab plus cisplatin in treating patients who have metastatic or recurrent cancer of the head and neck that has not responded to previous cisplatin-based chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Eli Lilly and Company; ImClone LLC; National Cancer Institute (NCI)
• Treatments: Cetuximab; Cisplatin; Fluorouracil; Paclitaxel

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