Overview
Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Status:
Completed
Completed
Trial end date:
2003-03-01
2003-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Daiichi Sankyo Inc.Daiichi Sankyo, Inc.
Treatments:
CevimelineCriteria
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