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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00017511
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Complications Radiation Toxicity Drug: cevimeline hydrochloride Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Supportive Care
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 Start Date : June 2001
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003






Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017511


  Hide Study Locations
Locations
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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Arizona
Cranial Pain Research
Tucson, Arizona, United States, 85711
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205-7199
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
Rebecca and John Moores UCSD Cancer Center
San Diego, California, United States, 92103-8757
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Colorado
Colorado Otolaryngology Associates
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-7106
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Innovative Medical Research of South Florida, Inc.
Miami, Florida, United States, 33138
United States, Georgia
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, United States, 30912
United States, Idaho
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7317
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7321
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202-3267
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112-2699
United States, Maryland
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287-0910
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Ear, Nose, and Throat Specialty Care of Minnesota, P.A.
Minneapolis, Minnesota, United States, 55404
University of Minnesota School of Dentistry
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110-1093
United States, Nebraska
University of Nebraska Medical Center
Lincoln, Nebraska, United States, 68583
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-1225
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Professional Otolaryngology Associates
Voorhees, New Jersey, United States, 08043
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
North Shore University Hospital
Manhasset, New York, United States, 11030
NYU - David B. Kriser Dental Center
New York, New York, United States, 10010-4086
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
State University of New York at Stony Brook School of Medicine
Stony Brook, New York, United States, 11794-8706
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center at Gaston Memorial
Gastonia, North Carolina, United States, 28053-1747
Matthews Radiation Oncology Center
Matthews, North Carolina, United States, 28105
Clinical Research of Winston Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Cancer Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-1333
Head and Neck Associates
Havertown, Pennsylvania, United States, 19083
Associated Otolaryngologist
Palmyra, Pennsylvania, United States, 17078
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Eye and Ear Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, United States, 37404
MultiSpecialty Clinical Research
Johnson City, Tennessee, United States, 37601
Dial Research Associates, Inc.
Nashville, Tennessee, United States, 37205
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-5671
United States, Texas
Baylor College of Dentistry
Dallas, Texas, United States, 75246
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Cancer Physicians Associates, PA
Laredo, Texas, United States, 78041
United States, Utah
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
McLean, Virginia, United States, 22101
United States, Washington
Seattle Institute for Biomedical and Clinical Research
Seattle, Washington, United States, 98108
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Southwest Washington Medical Center
Vancouver, Washington, United States, 98664
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Chair: Robert Vitti, MD Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00017511     History of Changes
Other Study ID Numbers: CDR0000068698
DAIICHI-2011A-PRT003/004
UCLA-0104045
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012
Keywords provided by Daiichi Sankyo, Inc.:
metastatic squamous neck cancer with occult primary squamous cell carcinoma
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 II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cevimeline
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action