DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer; Oral Complications; Radiation Toxicity

Intervention: cevimeline hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

Official(s) and/or principal investigator(s):
Robert Vitti, MD, Study Chair, Affiliation: Daiichi Sankyo Inc.


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.

Clinical Details

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Cevimeline in the Treatment of Xerostomia Secondary to Radiation Therapy for Cancer in the Head and Neck Region

Study design: Primary Purpose: Supportive Care

Detailed description: OBJECTIVES:

- Compare the efficacy of cevimeline vs placebo, in terms of dryness of the oral cavity

and salivary flow, in patients with xerostomia secondary to radiotherapy for cancers in the head and neck region.

- Assess the safety of this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral cevimeline 3 times daily for 12 weeks in the absence of

unacceptable toxicity.

- Arm II: Patients receive oral placebo as in arm I.

PROJECTED ACCRUAL: A total of 280 patients (140 per arm) will be accrued for this study.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- Hemoglobin at least 9. 0 g/dL

- No anemia


- 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


- Creatinine no greater than 2. 5 mg/dL

- BUN no greater than 50 mg/dL

- No history of nephrolithiasis within the past 6 months


- 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


- 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


- No prior or concurrent acute iritis or narrow-angle (angle closure) glaucoma

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception


- Not specified


- No concurrent chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No concurrent radiotherapy


- Not specified


- 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

Locations and Contacts

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294-3300, United States

Mobile Infirmary Medical Center, Mobile, Alabama 36607, United States

Cranial Pain Research, Tucson, Arizona 85711, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205-7199, United States

Alta Bates Comprehensive Cancer Center, Berkeley, California 94704, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

Chao Family Comprehensive Cancer Center, Orange, California 92868, United States

Radiation Oncology Center - Sacramento, Sacramento, California 95816, United States

Rebecca and John Moores UCSD Cancer Center, San Diego, California 92103-8757, United States

Stanford University Medical Center, Stanford, California 94305-5408, United States

Colorado Otolaryngology Associates, Colorado Springs, Colorado 80909, United States

University of Connecticut Health Center, Farmington, Connecticut 06360-7106, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

Innovative Medical Research of South Florida, Inc., Miami, Florida 33138, United States

Medical College of Georgia Hospital and Clinics, Augusta, Georgia 30912, United States

Kootenai Medical Center, Coeur d'Alene, Idaho 83814, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

University of Illinois at Chicago, Chicago, Illinois 60612-7317, United States

Evanston Northwestern Health Care, Evanston, Illinois 60201, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7321, United States

Central Baptist Hospital, Lexington, Kentucky 40503, United States

Louisville, Kentucky 40207, United States

James Graham Brown Cancer Center, Louisville, Kentucky 40202-3267, United States

Tulane Cancer Center, New Orleans, Louisiana 70112-2699, United States

Harbor Hospital Center, Baltimore, Maryland 21215-1290, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21287-0910, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Ear, Nose, and Throat Specialty Care of Minnesota, P.A., Minneapolis, Minnesota 55404, United States

University of Minnesota School of Dentistry, Minneapolis, Minnesota 55455, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

University of Missouri, Columbia, Missouri 65212, United States

Siteman Cancer Center, Saint Louis, Missouri 63110-1093, United States

University of Nebraska Medical Center, Lincoln, Nebraska 68583, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-1225, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire 03756-0002, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Monmouth Medical Center, Long Branch, New Jersey 07740-6395, United States

Professional Otolaryngology Associates, Voorhees, New Jersey 08043, United States

Albert Einstein Clinical Cancer Center, Bronx, New York 10461, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Mount Sinai Medical Center, NY, New York, New York 10029, United States

NYU - David B. Kriser Dental Center, New York, New York 10010-4086, United States

James P. Wilmot Cancer Center, Rochester, New York 14642, United States

State University of New York at Stony Brook School of Medicine, Stony Brook, New York 11794-8706, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Comprehensive Cancer Center at Gaston Memorial, Gastonia, North Carolina 28053-1747, United States

Matthews Radiation Oncology Center, Matthews, North Carolina 28105, United States

Clinical Research of Winston Salem, Winston-Salem, North Carolina 27103, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

Oregon Cancer Institute, Portland, Oregon 97239, United States

Geisinger Medical Center, Danville, Pennsylvania 17822-1333, United States

Head and Neck Associates, Havertown, Pennsylvania 19083, United States

Associated Otolaryngologist, Palmyra, Pennsylvania 17078, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104-4283, United States

Eye and Ear Institute, Pittsburgh, Pennsylvania 15213, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Memorial Hospital Cancer Center - Chattanooga, Chattanooga, Tennessee 37404, United States

MultiSpecialty Clinical Research, Johnson City, Tennessee 37601, United States

Dial Research Associates, Inc., Nashville, Tennessee 37205, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-5671, United States

Baylor College of Dentistry, Dallas, Texas 75246, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States

Cancer Physicians Associates, PA, Laredo, Texas 78041, United States

Latter Day Saints Hospital, Salt Lake City, Utah 84143, United States

McLean, Virginia 22101, United States

Seattle Institute for Biomedical and Clinical Research, Seattle, Washington 98108, United States

Madigan Army Medical Center, Tacoma, Washington 98431, United States

Southwest Washington Medical Center, Vancouver, Washington 98664, United States

Additional Information

Starting date: June 2001
Last updated: May 15, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017