Randomized Amifostine For SCCHN
Chemotherapeutic Agent Toxicity, Head and Neck Cancer, Mucositis
About this trial
This is an interventional treatment trial for Chemotherapeutic Agent Toxicity focused on measuring radiation toxicity, chemotherapeutic agent toxicity, mucositis, xerostomia, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, untreated metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma
Eligibility Criteria
Inclusion Criteria 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 K: 85 in woman serum creatinine in µmon/L K: 0.814 in man K: 0.96 in woman Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centers Previous chemotherapy is permitted, provided that it is in induction form before starting radiation therapy and that it is being used to treat head and neck cancers. Exclusion Criteria: 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.
Sites / Locations
- Goodall Hospital
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Bethke Cancer Center at Emerson Hospital
- Mass General/North Shore Cancer Center
- Saint Anne's Hospital - Fall River
- Lowell General Hospital
- Wentworth Douglass Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A Amifostine
Arm B No-Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received; 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). Subcutaneous daily amifostine at a dose of 500 mg
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN - 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).