Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Head and Neck Cancer, Oral Complications, Radiation Toxicity
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring stage I salivary gland cancer, stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, oral complications, stage I squamous cell carcinoma of the lip and oral cavity, stage I basal cell carcinoma of the lip, stage I verrucous carcinoma of the oral cavity, stage I mucoepidermoid carcinoma of the oral cavity, stage I adenoid cystic carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II basal cell carcinoma of the lip, stage II verrucous carcinoma of the oral cavity, stage II mucoepidermoid carcinoma of the oral cavity, stage II adenoid cystic carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III verrucous carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage I squamous cell carcinoma of the oropharynx, stage I lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage I inverted papilloma of the paranasal sinus and nasal cavity, stage I midline lethal granuloma of the paranasal sinus and nasal cavity, stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II inverted papilloma of the paranasal sinus and nasal cavity, stage II midline lethal granuloma of the paranasal sinus and nasal cavity, stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, radiation toxicity
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Mobile Infirmary Medical Center
- Cranial Pain Research
- University of Arkansas for Medical Sciences
- Alta Bates Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Chao Family Comprehensive Cancer Center
- Radiation Oncology Center - Sacramento
- Rebecca and John Moores UCSD Cancer Center
- Stanford University Medical Center
- Colorado Otolaryngology Associates
- University of Connecticut Health Center
- Walter Reed Army Medical Center
- Innovative Medical Research of South Florida, Inc.
- Medical College of Georgia Hospital and Clinics
- Kootenai Medical Center
- University of Illinois at Chicago
- University of Chicago Cancer Research Center
- Evanston Northwestern Health Care
- University of Kansas Medical Center
- Central Baptist Hospital
- James Graham Brown Cancer Center
- Tulane Cancer Center
- Harbor Hospital Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Dana-Farber Cancer Institute
- Barbara Ann Karmanos Cancer Institute
- Ear, Nose, and Throat Specialty Care of Minnesota, P.A.
- University of Minnesota School of Dentistry
- University of Mississippi Medical Center
- University of Missouri
- Siteman Cancer Center
- University of Nebraska Medical Center
- University of Nebraska Medical Center
- Norris Cotton Cancer Center
- Hackensack University Medical Center
- Monmouth Medical Center
- Professional Otolaryngology Associates
- Albert Einstein Clinical Cancer Center
- North Shore University Hospital
- NYU - David B. Kriser Dental Center
- Mount Sinai Medical Center, NY
- James P. Wilmot Cancer Center
- State University of New York at Stony Brook School of Medicine
- State University of New York - Upstate Medical University
- Duke Comprehensive Cancer Center
- Comprehensive Cancer Center at Gaston Memorial
- Matthews Radiation Oncology Center
- Clinical Research of Winston Salem
- Cleveland Clinic Taussig Cancer Center
- Oregon Cancer Institute
- Geisinger Medical Center
- Head and Neck Associates
- Associated Otolaryngologist
- University of Pennsylvania Cancer Center
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Eye and Ear Institute
- Medical University of South Carolina
- Memorial Hospital Cancer Center - Chattanooga
- MultiSpecialty Clinical Research
- Dial Research Associates, Inc.
- Vanderbilt-Ingram Cancer Center
- Baylor College of Dentistry
- University of Texas - MD Anderson Cancer Center
- Cancer Physicians Associates, PA
- Latter Day Saints Hospital
- Seattle Institute for Biomedical and Clinical Research
- Madigan Army Medical Center
- Southwest Washington Medical Center