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 ]
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