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Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer Clinical research trials and Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer clinical trial. Participants frequently get the best healthcare available for their Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer  Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
For Condition: radiation toxicity,oral complications of cancer and cancer therapy,paranasal sinus and nasal cavity cancer,lip and oral cavity cancer,Nasopharyngeal Cancer,Salivary Gland Cancer,metastatic squamous neck cancer with occult primary,Laryngeal Cancer,Oropharyngeal Cancer,Hypopharyngeal Cancer
Status: Recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertVitti, Study Chair, Daiichi Pharmaceuticals
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205-7199
United States
Recruiting Randall Breau 501-686-5140
James Graham Brown Cancer Center *Recruiting*
Louisville, Kentucky, 40202-3267
United States
Recruiting Zafrulla Khan 502-852-5747
NYU - David B. Kriser Dental Center *Recruiting*
New York City, New York, 10010-4086
United States
Recruiting Patrick Bivona 212-998-9385
University of Connecticut Health Center *Recruiting*
Farmington, Connecticut, 06360-7106
United States
Recruiting Douglas Peterson 860-679-2952
Seattle Institute for Biomedical and Clinical Research *Recruiting*
Seattle, Washington, 98108
United States
Recruiting Bevan Yueh 206-764-2424
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting John Suh 216-444-5574
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Mark Urken 212-241-5931
State University of New York at Stony Brook School of Medicine *Recruiting*
Stony Brook, New York, 11794-8706
United States
Recruiting Mark Wolff 631-632-8937
MultiSpecialty Clinical Research *Recruiting*
Johnson City, Tennessee, 37601
United States
Recruiting Wayne Gilbert 423-854-8952
Dana-Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Marshall Posner 617-632-3090
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting George Taybos 601-984-6077
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Guy Juillard 310-825-5268
Innovative Medical Research of South Florida, Inc. *Recruiting*
Miami, Florida, 33138
United States
Recruiting Marc Saltzman 305-757-2226
Rebecca and John Moores UCSD Cancer Center *Recruiting*
San Diego, California, 92103-8757
United States
Recruiting Francisco Pardo 619-692-9745
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Mark Chambers 713-792-6945
Medical College of Georgia Hospital and Clinics *Recruiting*
Augusta, Georgia, 30912
United States
Recruiting Christine Gourin 706-721-6100
Dial Research Associates, Inc. *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting Paul Rosenblatt 615-222-6755
Cranial Pain Research *Recruiting*
Tucson, Arizona, 85711
United States
Recruiting Theodore Kiersch 520-790-7246
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Richard Smith 718-430-2302
Cancer Physicians Associates, PA *Recruiting*
Laredo, Texas, 78041
United States
Recruiting Yadvindera Bains 956-796-4725
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Sophie Turner 516-562-4815
Clinical Research of Winston Salem *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting William Fisher 336-794-3273
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Anand Sharma 843-792-3533
Madigan Army Medical Center *Recruiting*
Tacoma, Washington, 98431
United States
Recruiting John Halligan 253-968-2090
University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612-7317
United States
Recruiting Fred Rosen 312-996-7975
Ear, Nose, and Throat Specialty Care of Minnesota, P.A. *Recruiting*
Minneapolis, Minnesota, 55404
United States
Recruiting Merrill Biel 612-871-1144
Geisinger Medical Center *Recruiting*
Danville, Pennsylvania, 17822-1333
United States
Recruiting Phillip Pellitteri 570-271-5040
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting John Casler 202-782-7818
State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Chung-Taik Chung 315-473-5276
Matthews Radiation Oncology Center *Recruiting*
Matthews, North Carolina, 28105
United States
Recruiting Steven Plunkett 704-367-9334
Colorado Otolaryngology Associates *Recruiting*
Colorado Springs, Colorado, 80909
United States
Recruiting John Hohengarten 719-867-7800
Southwest Washington Medical Center *Recruiting*
Vancouver, Washington, 98664
United States
Recruiting John Holland 360-514-1948
Chao Family Comprehensive Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting William Armstrong 714-281-4332
Comprehensive Cancer Center at Gaston Memorial *Recruiting*
Gastonia, North Carolina, 28053-1747
United States
Recruiting Charles Meakin 704-834-2944
Vanderbilt-Ingram Cancer Center *Recruiting*
Nashville, Tennessee, 37232-5671
United States
Recruiting A.J. Cmelak 615-322-2555
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Sharon Spencer 205-934-4763
Associated Otolaryngologist *Recruiting*
Palmyra, Pennsylvania, 17078
United States
Recruiting Roger Levin 717-832-0500
Central Baptist Hospital *Recruiting*
Lexington, Kentucky, 40503
United States
Recruiting Alan Beckman 859-260-6106
Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Glen Gejerman 201-996-2210
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting David Brizel 919-668-5637
University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7321
United States
Recruiting Eashwer Reddy 913-588-3600
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Adam Raben 732-923-6892
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Pramila Anne 215-503-4500
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110-1093
United States
Recruiting William Read 314-362-5268
Eye and Ear Institute *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Jonas Johnson 412-647-2130
University of Missouri *Recruiting*
Columbia, Missouri, 65212
United States
Recruiting Robert Zitsch 573-882-8174
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Donald Coleman 800-527-6266
Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5408
United States
Recruiting Quynh-Thu Le 650-723-6171
Norris Cotton Cancer Center *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Thomas Davis 603-650-6300
Head and Neck Associates *Recruiting*
Havertown, Pennsylvania, 19083
United States
Recruiting Joseph Ardito 610-296-5600
University of Nebraska Medical Center *Recruiting*
Lincoln, Nebraska, 68583
United States
Recruiting Gordon Mahanna 402-472-5168
Tulane Cancer Center *Recruiting*
New Orleans, Louisiana, 70112-2699
United States
Recruiting Lucien Nedzi 504-988-6302
Memorial Hospital Cancer Center - Chattanooga *Recruiting*
Chattanooga, Tennessee, 37404
United States
Recruiting Eric Ellis 423-495-8975
Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley, California, 94704
United States
Recruiting Elizabeth Tapen 510-204-5311
Baylor College of Dentistry *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Ibtisam Al-Hashimi 214-828-8490
Mobile Infirmary Medical Center *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting John Russell 251-435-3549
Evanston Northwestern Health Care *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Barry Wenig 847-570-2000
Professional Otolaryngology Associates *Recruiting*
Voorhees, New Jersey, 08043
United States
Recruiting Angelo Agro 856-346-0200
James P. Wilmot Cancer Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Yuhchyau Chen 716-275-5345
Harbor Hospital Center *Recruiting*
Baltimore, Maryland, 21215-1290
United States
Recruiting Jack Hong 410-355-0868
Radiation Oncology Center - Sacramento *Recruiting*
Sacramento, California, 95816
United States
Recruiting Christopher Jones 916-646-8300
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21287-0910
United States
Recruiting Wayne Koch 410-955-4906
Latter Day Saints Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting Vilija Avizonis 801-408-1030
Oregon Cancer Institute *Recruiting*
Portland, Oregon, 97239
United States
Recruiting John Holland 503-494-1617
University of Pennsylvania Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Randal Weber 215-662-6751
University of Minnesota School of Dentistry *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Nelson Rhodus 612-625-0693
University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-1225
United States
Recruiting Alan Richards 402-280-5009
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Daniel Haraf 773-702-5976
Kootenai Medical Center *Recruiting*
Coeur D Alene, Idaho, 83814
United States
Recruiting Haluk Tezcan 208-666-3800
Additional Information:
Study ID Numbers: CDR0000068698; UCLA-0104045,DAIICHI-2011A-PRT003/004
Study Start Date:
Record last reviewed: July 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017511
Other Metastatic Squamous Neck Cancer With Occult Primary Studies:
1. Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
2. Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
3. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Related Studies:
Other metastatic squamous neck cancer with occult primary Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
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