A Phase I/II Study Of OSI-774 In Combination With Cisplatin In Patients With Recurrent Or Metastatic Squamous Cell Cancer Of The Head And Neck

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck

- All primary sites, including oral cavity, oropharynx, nasopharynx, hypopharynx,
larynx, and paranasal sinus

- Recurrent, unresectable, and/or metastatic disease

- At least 1 measurable lesion

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

- Lesions accessible for biopsy

- Tumor specimen available for evaluation of epidermal growth factor receptor (EGFR)
expression

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy:

- More than 12 weeks

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 no greater than 1.25 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN

Renal:

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Gastrointestinal:

- No gastrointestinal tract disease resulting in malabsorption

- No requirement for IV alimentation

- No active peptic ulcer disease

- Inability to swallow tablets or silicon-based G-tubes allowed

Ophthalmic:

- No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjogren's
syndrome)

- No congenital abnormality (e.g., Fuch's dystrophy)

- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or
Bengal-Rose)

- No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production
test)

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except carcinoma in situ of the cervix,
nonmelanoma skin cancer, or second primary squamous cell cancer originating from the
head and neck

- No grade 2 or greater residual ototoxicity or neuropathy from prior platinum-based
therapy

- No significant traumatic injury within the past 21 days

- No other concurrent uncontrolled illness

- No ongoing or active infection

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for recurrent or metastatic disease

- Prior platinum-based chemotherapy with radiotherapy or platinum-based induction
chemotherapy allowed

- At least 6 months since prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Chemotherapy

- At least 4 weeks since prior radiotherapy (except low-dose, limited-fraction
palliative non-myelosuppressive radiotherapy [e.g., involving less than 20% of
functioning bone marrow using 800 cGy in 1 fraction or 2,000 cGy in 5 fractions]) and
recovered

- No prior radiotherapy to target lesion unless there is evidence of disease
progression

Surgery:

- See Disease Characteristics

- At least 21 days since prior major surgery

- No prior surgical procedure affecting gastrointestinal absorption

Other:

- No prior EGFR-targeting therapies

- No prior investigational agents for recurrent or metastatic disease

- No concurrent combination anti-retroviral therapy for HIV infection

- No other concurrent investigational agents

- No other concurrent anticancer treatment