A Phase II Study of Single-Agent OSI-7904L in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed First-Line Therapy

Inclusion Criteria:

Histologically or cytologically confirmed metastatic or locally recurrent SCCHN that is
incurable with surgery or radiation therapy ECOG performance status 0-2 No more tha 1
prior chemotharapy regimen for metastatic or locally recurrent disease Adequate bone
marrow, Hepatic and renal function. At least one target lesion greater than or equal to 20
mm.

Exclusion Criteria:

Symptomatic brain metasteses which are not stable, are not adequately controlled, are
potenially life threatening or required radiation in the last 28 days Pregnant or
lactating women. Concurrent anticancer therapy or other investigational drugs Patients
with active or uncontrolled infections or other serious illnesses or medical conditions.