A Phase II Study of ZD 1839 (Iressa) in Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed primary squamous cell cancer of the head
and neck that is incurable by surgery or radiotherapy

- Stratum I:

- Failed surgery and/or radiotherapy and received no prior systemic
chemotherapy for recurrent disease OR

- Recurrent disease at least 6 months after prior multimodal primary therapy
including neoadjuvant or concurrent chemotherapy OR

- Metastatic disease at initial diagnosis and received no prior chemotherapy

- Stratum II:

- No more than 1 prior chemotherapy regimen for recurrent disease OR

- Recurrent disease within 6 months after prior primary therapy that included
chemotherapy

- Measurable disease

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Clear clinical evidence of progression or biopsy-proven residual cancer required
if only site of measurable disease is in a previously irradiated field

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin normal (no greater than 1.5 times upper limit of normal [ULN] if liver
metastases present)

- AST/ALT no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other:

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No prior allergic reactions attributed to compounds of similar chemical or biologic
composition to gefitinib

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior therapy with agents that target epidermal growth factor receptors

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy:

- No concurrent tamoxifen

Radiotherapy:

- Prior radiotherapy as primary or secondary treatment allowed

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- Prior surgery as primary or secondary treatment allowed

- At least 4 weeks since prior major surgery

Other:

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV

- No concurrent 3A4 inhibitors (e.g., ketoconazole, erythromycin, verapamil)

- No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone,
chloroquine)