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| Sponsor: | Daiichi Sankyo Inc. |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017511 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Oral Complications Radiation Toxicity |
Drug: cevimeline hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | 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 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 280 patients (140 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Received more than 4,000 cGy of prior external beam radiotherapy for cancer in the head and neck region
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36607 | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| 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 | |
| Radiation Oncology Center - Sacramento | |
| Sacramento, California, United States, 95816 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| 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 | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7317 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7321 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40207 | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202-3267 | |
| 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 | |
| Siteman Cancer Center | |
| Saint Louis, Missouri, United States, 63110-1093 | |
| University of Missouri | |
| Columbia, Missouri, United States, 65212 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-1225 | |
| University of Nebraska Medical Center | |
| Lincoln, Nebraska, United States, 68583 | |
| 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 | |
| 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 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14642 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| State University of New York at Stony Brook School of Medicine | |
| Stony Brook, New York, United States, 11794-8706 | |
| United States, North Carolina | |
| Clinical Research of Winston Salem | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Comprehensive Cancer Center at Gaston Memorial | |
| Gastonia, North Carolina, United States, 28053-1747 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Matthews Radiation Oncology Center | |
| Matthews, North Carolina, United States, 28105 | |
| 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 | |
| Associated Otolaryngologist | |
| Palmyra, Pennsylvania, United States, 17078 | |
| Eye and Ear Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-1333 | |
| Head and Neck Associates | |
| Havertown, Pennsylvania, United States, 19083 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Dial Research Associates, Inc. | |
| Nashville, Tennessee, United States, 37205 | |
| Memorial Hospital Cancer Center - Chattanooga | |
| Chattanooga, Tennessee, United States, 37404 | |
| MultiSpecialty Clinical Research | |
| Johnson City, Tennessee, United States, 37601 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-5671 | |
| United States, Texas | |
| Baylor College of Dentistry | |
| Dallas, Texas, United States, 75246 | |
| Cancer Physicians Associates, PA | |
| Laredo, Texas, United States, 78041 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| 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 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
| Seattle Institute for Biomedical and Clinical Research | |
| Seattle, Washington, United States, 98108 | |
| Southwest Washington Medical Center | |
| Vancouver, Washington, United States, 98664 | |
| Study Chair: | Robert Vitti, MD | Daiichi Sankyo Inc. |
More Information
| Study ID Numbers: | CDR0000068698, DAIICHI-2011A-PRT003/004, UCLA-0104045 |
| Study First Received: | June 6, 2001 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017511 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Parasympathomimetics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Cevimeline Autonomic Agents Head and Neck Neoplasms Muscarinic Agonists Peripheral Nervous System Agents |