Overview

A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy

Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
0
Participant gender:
All
Summary
Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck cancer in patients who have failed first-line therapy
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
OSI Pharmaceuticals
Criteria
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.