Randomized, Double Blind, Placebo Controlled Phase III Evaluation of Cisplatin + Placebo Versus Cisplatin + C225 a Mouse/Human Monoclonal Antibody to the Epidermal Growth Factor Receptor, in Patients With Metastatic and/or Recurrent Squamous Cell Cancer of the Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and
neck that is incurable with surgery or radiotherapy No nasopharyngeal primaries Measurable
or evaluable disease Newly diagnosed with extensive, incurable local regional disease AND
distant metastases OR Local regional recurrence/persistence or distant metastases after
surgery or radiotherapy Persistent or progressive disease after radiotherapy must be
histologically proven at least 8 weeks after therapy No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin
no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal
(ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than
1.2 mg/dL OR Creatinine clearance at least 50 mL/min Calcium no greater than ULN No
history of hypercalcemia Other: No active infection No other concurrent malignancy within
past 2 years except curatively treated basal cell or squamous cell skin cancer or
carcinoma in situ of the cervix No known hypersensitivity to murine proteins Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior chimeric antibody or kinase inhibitor
for recurrent or metastatic disease No more than 1 prior biotherapy regimen for recurrent
or metastatic disease Chemotherapy: At least 3 months since prior induction or adjuvant
chemotherapy concurrent with radiotherapy No prior chemotherapy for recurrent disease
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4
weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior
major surgery