Clinical Trial: Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer

Brief Summary: To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer

Detailed Summary:

Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.

The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.


Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Current Primary Outcome: Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer [ Time Frame: Day 36 ]

To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.


Original Primary Outcome: The primary endpoint of this study is toxicity, specifically the rate of Dose Limiting toxicity (DLT).

Current Secondary Outcome:

  • Determination of Dose Limiting Toxicity (DTL) [ Time Frame: 30 days ]
    To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.
  • Complete Remission Rate [ Time Frame: 6 months ]
    To obtain preliminary data on the complete remission rate for this treatment combination.


Original Secondary Outcome:

Information By: Thomas Jefferson University

Dates:
Date Received: November 29, 2006
Date Started: December 2006
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016