Locally Recurrent or Metastatic Cancer of the Head and Neck Clinical Trial
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
| Verified date | March 2007 |
| Source | OSI Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | August 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Sarah Cannon Cancer Center | Nashville | Tennessee |
| United States | The Vanderbilt Cancer Center | Nashville | Tennessee |
| United States | Stony Brook University Hospital | Stony Brook | New York |
| Lead Sponsor | Collaborator |
|---|---|
| OSI Pharmaceuticals |
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