Stopped: The study did not continue to phase II due to the importance of HPV status as a prognostic factor to guide treatment decisions.
The purpose of the Phase I part of this research study is to determine the safest and most effective dose of Abraxane when given in combination with carboplatin and Erbitux during radiation therapy for head and neck cancer. The purpose of the Phase II part of this study is to determine the effects of the treatment on head and neck cancers, as well as to further study the safety of this treatment.
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Abraxane Maximum Tolerated Dose (MTD) [Phase I]
Timeframe: Adverse event assessments occurred weekly on treatment; The observation period for MTD evaluation incorporated the 7 weeks of treatment.
Dose Limiting Toxicity (DLT) [Phase I]
Timeframe: Adverse event assessments occurred weekly on treatment; The observation period for DLT evaluation incorporated the 7 weeks of treatment.
2-Year Disease-Free Survival [Phase II]
Timeframe: Disease assessments occurred 8-10 weeks following treatment end then every 4-6 weeks (yr 1), every 8-10 weeks (yr 2), quarterly (yr 3) and semiannually up to 2 yrs since last pt enrolled.