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

This study has been completed.

Sponsored by:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00116909

Purpose

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

Condition	Intervention	Phase
Locally Recurrent or Metastatic Cancer of the Head and Neck Must Have Failed First-Line Therapy	Drug: OSI 7904L	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	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

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment:	85
Study Start Date:	August 2004
Estimated Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116909

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
The Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

Study ID Numbers:	OSI-904-203
Study First Received:	June 30, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00116909
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epidermoid carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasm Metastasis

Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Recurrence
Carcinoma

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009