Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Received more than 4,000 cGy of prior external beam radiotherapy for cancer in the head and neck region
• * Radiotherapy completed more than 4 months prior to study
• Clinically significant salivary gland dysfunction with grade 2 or 3 xerostomia
• At least 1 anatomically intact parotid gland
• No suspected or confirmed bilateral physical closure of salivary gland ducts
• No history of primary or secondary Sjogren's syndrome or other underlying systemic illness known to cause xerostomia independent of prior radiotherapy exposure
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• Karnofsky 70-100%
• ECOG 0-2
• Life expectancy:
• At least 6 months
• Hematopoietic:
• Hemoglobin at least 9.0 g/dL
• No anemia
• Hepatic:
• Bilirubin no greater than 2 times upper limit of normal (ULN)
• SGOT/SGPT no greater than 2 times ULN
• Lactate dehydrogenase no greater than 2 times ULN
• No evidence of active liver disease
• Renal:
• Creatinine no greater than 2.5 mg/dL
• BUN no greater than 50 mg/dL
• No history of nephrolithiasis within the past 6 months
• Cardiovascular:
• No history of significant cardiovascular disease
• No active congestive heart failure
• No uncontrolled angina
• No significant arrhythmia
• No myocardial infarction within the past 6 months
• Pulmonary:
• No history of significant pulmonary disease
• No controlled or uncontrolled asthma
• No chronic bronchitis or chronic obstructive pulmonary disease that would limit avocational activities
• Gastrointestinal:
• No history of significant gastrointestinal disorder
• No active pancreatic disease
• No gastroduodenal ulcers within the past 6 months
• No hypersensitive bowel conditions requiring pharmacologic therapy
• No inflammatory bowel disease
• No history of cholelithiasis within the past 6 months (unless cholecystectomy performed)
• Other:
• No clinically significant laboratory abnormality
• No history of alcohol or drug abuse within the past 6 months that would preclude study
• No prior or concurrent acute iritis or narrow-angle (angle closure) glaucoma
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• No concurrent chemotherapy
• Endocrine therapy:
• Not specified
• Radiotherapy:
• See Disease Characteristics
• No concurrent radiotherapy
• Surgery:
• Not specified
• Other:
• At least 30 days since other investigational new drug
• At least 4 weeks since prior systemic or ophthalmic pilocarpine
• No prior cevimeline
• No concurrent hyperbaric oxygen therapy
• No concurrent beta adrenergic antagonists, anticholinergic agents, cevimeline metabolism inhibitors, or other medications known to effect salivary function
• No other concurrent investigational drugs