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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00116909
First Posted: July 1, 2005
Last Update Posted: March 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
OSI Pharmaceuticals
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by OSI Pharmaceuticals:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00116909     History of Changes
Other Study ID Numbers: OSI-904-203
First Submitted: June 30, 2005
First Posted: July 1, 2005
Last Update Posted: March 14, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Neoplasm Metastasis
Head and Neck Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site