Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
A Phase I/II Trial of Abraxane in Combination With Carboplatin, Erbitux and Intensity Modulated Radiation Therapy (IMRT)for Treatment of Locally Advanced Squamous Cancer of the Head and Neck
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.
Primary Objectives
1. Phase I—To identify the maximally tolerated dose (MTD) of Abraxane given with
carboplatin plus concurrent IMRT (AC-RT)
2. Phase II—To evaluate efficacy in the phase II portion of the study by evaluating 2-year
disease-free survival
Secondary Objectives
1. To evaluate the safety and tolerability
2. To estimate the overall response rate
3. To estimate 2-year overall survival
4. To evaluate functional outcome at 2 years with respect to speech, swallowing and overall
quality of life (QoL), by determining mean duration of PEG-dependence and change in
FACT-HN scores from baseline to 3, 6, 12 and 24 months.
STATISTICAL DESIGN:
The Phase I study followed a standard 3+3 dose escalation design. Four potential dose levels
of Abraxane ultimately were under evaluation including a de-escalation dose level -1. [Note:
Erbitux was originally planned to be given with carboplatin and Abraxane, but removed due to
toxicity experienced at dose level 1.] The DLT observation period is the 7 weeks of
treatment. The Phase I incorporated a10-patient expansion cohort to ensure that the toxicity
at the MTD for AC-RT was acceptable. Planned enrollment for the Phase II study was 34
patients primarily to test whether 2-year disease-free survival was consistent with 75% rate
as opposed to the null hypothesis of 53.5% based on prior research (RTOG 99-14).
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