A Phase II Stdy of ZD 1839 in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent
squamous cell carcinoma of the head and neck that is incurable by surgery or radiotherapy
At least 1 lesion measurable in at least 1 dimension At least 20 mm by conventional
techniques OR At least 10 mm by CT scan No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100%
Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute
neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no
greater than 1.5 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable
angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception No history of allergic reactions to
compounds of similar chemical or biological composition to ZD 1839 No active infection No
other uncontrolled illness No psychiatric illness or social situation that would preclude
study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior epidermal growth factor
receptor-based therapy for recurrent disease Chemotherapy: No more than 1 prior adjuvant
or neoadjuvant chemotherapy and/or chemoradiotherapy regimen At least 4 weeks since prior
chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Not
specified Radiotherapy: See Disease Characteristics See Chemotherapy At least 4 weeks
since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No more
than 1 prior regimen for recurrent disease No other concurrent investigational agents No
concurrent combination antiretroviral therapy for HIV