Randomized Amifostine For SCCHN

Completed · Phase 2

Conditions studied: Chemotherapeutic Agent Toxicity, Head and Neck Cancer, Mucositis, Radiation Toxicity, Xerostomia

In brief

This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.

Key facts

Study ID

NCT00095927

Run by

Dana-Farber Cancer Institute

People needed

58

Starts

2003-05-01

Expected to finish

2008-06-01

Last updated by the study team

2017-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated.
• Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary SCC in the neck will also be eligible.
• Stage 2, 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound or CT (in case of liver function test abnormalities); bone scan in case of local symptoms.
• At least one uni- or bidimensionally measurable lesion at the start of all therapy (induction therapy ag well as chemoradiation).
• No previous head and neck radiotherapy and no previous curative surgery for SCCHN (other than biopsy) are allowed at time of study entry.
• Age ≥ 18 years.
• WHO performance status of 0 or 1 (section 13, Appendix I)
• No active alcohol addiction (as assessed by medical caregiver).
• Life expectancy ≥ 12 weeks.
• Signed informed consent prior to beginning protocol specific procedures.
• Adequate bone marrow, hepatic and renal functions as evidenced by the following:
• Hematology:
• neutrophil count ≥ 2.0 x 10 9/1.
• platelet count ≥ 100 x 10 9/1.
• hemoglobin ≥ 10 g/dl.
• Hepatic function:
• total bilinthin WNL.
• ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x 1JLN.
• alkaline phosphatase ≤ 5 x ULN.
• patients with ASAT or ALAT > 1.5 x ULN associated with alkaline phosphatase > 2.5
• x ULN are not eligible for the study.
• Renal function: the creatinine clearance ≥ 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows:
• Weight(kg) x (140 - age)/K x serum creatinine
• serum creatinine in mg/dL
• K: 72 in man

You may not qualify if…

• Pregnant or lactating women, or women of childbearing potential not using adequate contraception.
• Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 3 years.
• Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria.
• Other serious illnesses or medical conditions including but not limited to:
• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
• History of significant neurologic or psychiatric disorders including dementia or seizures.
• Active uncontrolled infection.
• Active peptic ulcer.
• Hypercalcemia.
• Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
• Patients requiring intravenous alimentation.
• Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry (unless purposeful)
• Concurrent treatment with any other anticancer therapy.
• Participation in an investigational trial within 30 days of study entry.
• Previous treatment with any biologic therapy is not permitted.

Where it is running

• Goodall Hospital — Sanford, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• 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

Full record on ClinicalTrials.gov

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