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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Locally Recurrent or Metastatic Cancer of the Head and Neck, Must Have Failed First-Line Therapy

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Trial Information

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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

OSI-904-203

NCT ID:

NCT00116909

Start Date:

August 2004

Completion Date:

August 2005

Related Keywords:

  • Locally Recurrent or Metastatic Cancer of the Head and Neck
  • Must Have Failed First-Line Therapy
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Sarah Cannon Cancer CenterNashville, Tennessee  37203
Stony Brook University HospitalStony Brook, New York  11794-8174
The Vanderbilt Cancer CenterNashville, Tennessee  37232