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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017511
• Other study ID #: CDR0000068698
• Secondary ID: DAIICHI-2011A-PR
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2001
• Last updated: May 15, 2012
• Start date: June 2001
• Est. completion date: March 2003

Study information

• Verified date: May 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Oral Complications
• Radiation Injuries
• Radiation Toxicity

Intervention

Drug:
• cevimeline hydrochloride

Locations

Country	Name	City	State
United States	Medical College of Georgia Hospital and Clinics	Augusta	Georgia
United States	Harbor Hospital Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Memorial Hospital Cancer Center - Chattanooga	Chattanooga	Tennessee
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Kootenai Medical Center	Coeur d'Alene	Idaho
United States	Colorado Otolaryngology Associates	Colorado Springs	Colorado
United States	University of Missouri	Columbia	Missouri
United States	Baylor College of Dentistry	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Comprehensive Cancer Center at Gaston Memorial	Gastonia	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Head and Neck Associates	Havertown	Pennsylvania
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	MultiSpecialty Clinical Research	Johnson City	Tennessee
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Cancer Physicians Associates, PA	Laredo	Texas
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Central Baptist Hospital	Lexington	Kentucky
United States	University of Nebraska Medical Center	Lincoln	Nebraska
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Matthews Radiation Oncology Center	Matthews	North Carolina
United States	Innovative Medical Research of South Florida, Inc.	Miami	Florida
United States	Ear, Nose, and Throat Specialty Care of Minnesota, P.A.	Minneapolis	Minnesota
United States	University of Minnesota School of Dentistry	Minneapolis	Minnesota
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Dial Research Associates, Inc.	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center, NY	New York	New York
United States	NYU - David B. Kriser Dental Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Associated Otolaryngologist	Palmyra	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Eye and Ear Institute	Pittsburgh	Pennsylvania
United States	Oregon Cancer Institute	Portland	Oregon
United States	James P. Wilmot Cancer Center	Rochester	New York
United States	Radiation Oncology Center - Sacramento	Sacramento	California
United States	Siteman Cancer Center	Saint Louis	Missouri
United States	Latter Day Saints Hospital	Salt Lake City	Utah
United States	Rebecca and John Moores UCSD Cancer Center	San Diego	California
United States	Seattle Institute for Biomedical and Clinical Research	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	State University of New York at Stony Brook School of Medicine	Stony Brook	New York
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Cranial Pain Research	Tucson	Arizona
United States	Southwest Washington Medical Center	Vancouver	Washington
United States	Professional Otolaryngology Associates	Voorhees	New Jersey
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Clinical Research of Winston Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States,