Status:
COMPLETED
A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy
Lead Sponsor:
OSI Pharmaceuticals
Conditions:
Locally Recurrent or Metastatic Cancer of the Head and Neck
Must Have Failed First-Line Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00116909
Start Date
August 1 2004
End Date
August 1 2005
Last Update
March 14 2007
Active Locations (4)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
3
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
4
The Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232