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

May 15, 2012 updated by: Daiichi Sankyo, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Investigators

  • Study Chair: Robert Vitti, MD, Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

June 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068698
  • DAIICHI-2011A-PRT003/004
  • UCLA-0104045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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