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

Phase 2

Completed

• Conditions: Locally Recurrent or Metastatic Cancer of the Head and Neck; Must Have Failed First-Line Therapy

• Registration Number: NCT00116909
• Lead Sponsor: OSI Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-01
• Study Completion: 2005-08
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-13
• Last Update Posted: 2007-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States

Sarah Cannon Cancer Center; 🇺🇸 Nashville, Tennessee, United States

The Vanderbilt Cancer Center; 🇺🇸 Nashville, Tennessee, United States