Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck

Study Overview
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Brief Summary
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The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.

Official Title
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A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Radiation: Stereotactic Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent or second primary squamous cell head and neck cancer Defined area of recurrence on imaging Previous head and neck radiation (RT) to >/= 50 Gy Performance status score 0-1 Time interval from previous RT >/= 9 months Volume of disease appropriate for protocol treatment Minimum estimated survival of >/= 3 months Age >/= 18 Adequate labs Exclusion Criteria: Primary tumors of the salivary gland Original pathology report and radiation therapy records not available Prior spinal cord dose > 45 Gy Surgery or chemotherapy within 4 weeks Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel + Stereotactic Radiation<br>Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by > 48 hours. | Drug: Docetaxel<br>* Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT<br>* Other names: NDC 0075-8001-20;Radiation: Stereotactic Radiation<br>* SBRT will be given over 5 fractions separated by > 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy.<br>* Other names: Radiation Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of acute dose limiting toxicities | Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control | Time from enrollment until local failure or death (whichever comes first) | 2 years | 
| Disease-free survival | Time from enrollment until disease progression anywhere in the body or death (whichever comes first) | 2 years | 
| overall survival | Time from enrollment to death from any cause | 2 years | 
| Number of late effect dose limiting toxicities | Occuring > 3 months after treatment completion, including grade 4 and 5 toxicities measured by CTCAE v 4.0 involving skin, mucosa, larynx, pharynx, spinal cord, cranial nerves, and incidence of caroid blowout. | 2 years |