This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.
Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form. The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Goodall Hospital
Sanford, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Rate of local/regional control (LRC) 1 year after beginning treatment
Time frame: One year after beginning of treatment
Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months
Time frame: 3, 6 Months
Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy
Time frame: End of Radiotherapy
Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment
Time frame: 8,12, 24 and 52 weeks
Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment
Time frame: 8, 12, 24, and 52 weeks
Proportion of patients with PEG dependency
Time frame: 3, 6, and 12 months after completion of study treatment
Time to disease progression
Kaplan and Meier
Time frame: baseline to disease progression
Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey
Time frame: baseline, 8, 12, 24, and 52 weeks after completion of study treatment
LRC and overall survival at 2 years after completion of study treatment
Time frame: 2 Years after completion of study treatment
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Given once daily for 4 weeks and then twice daily for 2 weeks.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States
Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Wentworth Douglass Hospital
Dover, New Hampshire, United States
Swallowing function
Time frame: 2 years Post treatment