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Head and Neck CancerPhase 3NCT00017511

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

A Phase 3 study testing cevimeline hydrochloride in people with Head and Neck Cancer and Oral Complications, run by Daiichi Sankyo at 71 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cevimeline hydrochloride
How many people
Not given
Where
71 sitesUnited States
Study dates
Jun 2001to Mar 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

71 sites in 1 country.

71 sites in 1 country

United States71 sites

  • Medical College of Georgia Hospital and Clinics

    Augusta, Georgia, 30912

  • Harbor Hospital Center

    Baltimore, Maryland, 21215-1290

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287-0910

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Memorial Hospital Cancer Center - Chattanooga

    Chattanooga, Tennessee, 37404

  • University of Illinois at Chicago

    Chicago, Illinois, 60612-7317

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Colorado Otolaryngology Associates

    Colorado Springs, Colorado, 80909

  • University of Missouri

    Columbia, Missouri, 65212

  • Baylor College of Dentistry

    Dallas, Texas, 75246

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1333

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Evanston Northwestern Health Care

    Evanston, Illinois, 60201

  • University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Comprehensive Cancer Center at Gaston Memorial

    Gastonia, North Carolina, 28053-1747

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Head and Neck Associates

    Havertown, Pennsylvania, 19083

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • MultiSpecialty Clinical Research

    Johnson City, Tennessee, 37601

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7321

  • Cancer Physicians Associates, PA

    Laredo, Texas, 78041

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • University of Nebraska Medical Center

    Lincoln, Nebraska, 68583

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205-7199

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202-3267

  • Study site

    Louisville, Kentucky, 40207

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Matthews Radiation Oncology Center

    Matthews, North Carolina, 28105

  • Study site

    McLean, Virginia, 22101

  • Innovative Medical Research of South Florida, Inc.

    Miami, Florida, 33138

  • Ear, Nose, and Throat Specialty Care of Minnesota, P.A.

    Minneapolis, Minnesota, 55404

  • University of Minnesota School of Dentistry

    Minneapolis, Minnesota, 55455

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

  • Dial Research Associates, Inc.

    Nashville, Tennessee, 37205

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-5671

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112-2699

  • NYU - David B. Kriser Dental Center

    New York, New York, 10010-4086

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-1225

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Associated Otolaryngologist

    Palmyra, Pennsylvania, 17078

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Eye and Ear Institute

    Pittsburgh, Pennsylvania, 15213

  • Oregon Cancer Institute

    Portland, Oregon, 97239

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • Radiation Oncology Center - Sacramento

    Sacramento, California, 95816

  • Latter Day Saints Hospital

    Salt Lake City, Utah, 84143

  • Rebecca and John Moores UCSD Cancer Center

    San Diego, California, 92103-8757

  • Seattle Institute for Biomedical and Clinical Research

    Seattle, Washington, 98108

  • Siteman Cancer Center

    St Louis, Missouri, 63110-1093

  • Stanford University Medical Center

    Stanford, California, 94305-5408

  • State University of New York at Stony Brook School of Medicine

    Stony Brook, New York, 11794-8706

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Albert Einstein Clinical Cancer Center

    The Bronx, New York, 10461

  • Cranial Pain Research

    Tucson, Arizona, 85711

  • Southwest Washington Medical Center

    Vancouver, Washington, 98664

  • Professional Otolaryngology Associates

    Voorhees Township, New Jersey, 08043

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Clinical Research of Winston Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
cevimeline hydrochloride
Keywords
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
Medical subject headings
Head and Neck Neoplasms, Radiation Injuries, Salivary Gland Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cevimeline hydrochlorideDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2001
  3. Primary completionMar 2003
  4. Study completionMar 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017511
Sponsor's protocol ID
CDR0000068698
Other IDs
DAIICHI-2011A-PRT003/004, UCLA-0104045
Status last verified
May 2012
First submitted
6 Jun 2001
Last updated
16 May 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cevimeline hydrochloride in people with Head and Neck Cancer and Oral Complications, run by Daiichi Sankyo at 71 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00017511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.

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