A Phase I and Phase II Study of OSI-774 in Combination With Docetaxel in Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- Histologically or cytologically confirmed squamous cell carcinoma of the head and
neck meeting 1 of the following staging criteria:

- Recurrent

- Metastatic

- Locally advanced and determined to be incurable by surgery or radiotherapy

- Measurable disease

- No known brain metastases

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- WBC at least 3,000/mm^3

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

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

- Bilirubin normal

- AST and ALT no greater than 2.5 times upper limit of normal

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No severe pulmonary insufficiency, including chronic obstructive pulmonary disease,
requiring oxygen (O2 saturation less than 90%) and/or increase in PaCO2 blood gas
level greater than 50 mm Hg

- No history of abnormality of the cornea (e.g., dry eye syndrome or Sjögren'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 (Schirmer test or similar tear production test)

- Able to take oral medication

- No requirement for IV alimentation

- No active peptic ulcer disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant traumatic injury within the past 21 days

- No prior allergic reactions to compounds of similar chemical or biological
composition to study drugs

- No grade 2 or greater persistent peripheral neuropathy

- No other concurrent uncontrolled illness that would preclude study participation

- No ongoing or active infection

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

- No prior immunotherapy for head and neck cancer

- No more than 1 prior chemotherapy regimen in the adjuvant or neoadjuvant setting

- No more than 1 prior chemotherapy regimen for metastatic disease

- No prior docetaxel (phase II only)

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

- No prior hormonal therapy for head and neck cancer

- Prior external beam radiotherapy allowed

- At least 4 weeks since prior radiotherapy and recovered

- More than 21 days since prior major surgery

- No prior surgery affecting gastrointestinal absorption

- No prior epidermal growth factor receptor-targeting therapy

- No other concurrent investigational agents

- No other concurrent anticancer therapies or agents

- No concurrent combination antiretroviral therapy for HIV-positive patients