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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Oral Complications, Radiation Toxicity

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Robert Vitti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000068698

NCT ID:

NCT00017511

Start Date:

June 2001

Completion Date:

March 2003

Related Keywords:

  • Head and Neck Cancer
  • Oral Complications
  • Radiation Toxicity
  • 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
  • recurrent basal cell carcinoma of the lip
  • recurrent verrucous carcinoma of the oral cavity
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • recurrent adenoid cystic carcinoma of the oral cavity
  • stage I squamous cell carcinoma of the oropharynx
  • stage I lymphoepithelioma of the oropharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage II lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent lymphoepithelioma of the oropharynx
  • stage I squamous cell carcinoma of the nasopharynx
  • stage I lymphoepithelioma of the nasopharynx
  • stage II squamous cell carcinoma of the nasopharynx
  • stage II lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • stage I squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage I verrucous carcinoma of the larynx
  • stage II squamous cell carcinoma of the larynx
  • stage II verrucous carcinoma of the larynx
  • stage III squamous cell carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage I inverted papilloma of the paranasal sinus and nasal cavity
  • stage I midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage II inverted papilloma of the paranasal sinus and nasal cavity
  • stage II midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III inverted papilloma of the paranasal sinus and nasal cavity
  • stage III midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • radiation toxicity
  • Head and Neck Neoplasms
  • Radiation Injuries

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Mount Sinai Medical Center, NYNew York, New York  10029
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Radiation Oncology Center - SacramentoSacramento, California  95816
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Harbor Hospital CenterBaltimore, Maryland  21225
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Evanston Northwestern Health CareEvanston, Illinois  60201
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Madigan Army Medical CenterTacoma, Washington  98431-5048
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of MissouriColumbia, Missouri  65212
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
James P. Wilmot Cancer CenterRochester, New York  14642
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Oregon Cancer InstitutePortland, Oregon  97201-3098
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
University of Connecticut Health CenterFarmington, Connecticut  06360-7106
University of Illinois at ChicagoChicago, Illinois  60612
Central Baptist HospitalLexington, Kentucky  40503
Latter Day Saints HospitalSalt Lake City, Utah  84143
Medical College of Georgia Hospital and ClinicsAugusta, Georgia  30912-3620
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Tulane Cancer CenterNew Orleans, Louisiana  70112
Ear, Nose, and Throat Specialty Care of Minnesota, P.A.Minneapolis, Minnesota  55404
Siteman Cancer CenterSaint Louis, Missouri  63110
Dial Research Associates, Inc.Nashville, Tennessee  37205
Memorial Hospital Cancer Center - ChattanoogaChattanooga, Tennessee  37404
Cranial Pain ResearchTucson, Arizona  85711
Colorado Otolaryngology AssociatesColorado Springs, Colorado  80909
Innovative Medical Research of South Florida, Inc.Miami, Florida  33138
Kootenai Medical CenterCoeur d'Alene, Idaho  83814
Louisville, Kentucky  40207
University of Minnesota School of DentistryMinneapolis, Minnesota  55455
Professional Otolaryngology AssociatesVoorhees, New Jersey  08043
NYU - David B. Kriser Dental CenterNew York, New York  10010-4086
State University of New York at Stony Brook School of MedicineStony Brook, New York  11794-8706
Comprehensive Cancer Center at Gaston MemorialGastonia, North Carolina  28053-1747
Matthews Radiation Oncology CenterMatthews, North Carolina  28105
Clinical Research of Winston SalemWinston-Salem, North Carolina  27103
Head and Neck AssociatesHavertown, Pennsylvania  19083
Associated OtolaryngologistPalmyra, Pennsylvania  17078
Eye and Ear InstitutePittsburgh, Pennsylvania  15213
MultiSpecialty Clinical ResearchJohnson City, Tennessee  37601
Baylor College of DentistryDallas, Texas  75246
Cancer Physicians Associates, PALaredo, Texas  78041
McLean, Virginia  22101
Seattle Institute for Biomedical and Clinical ResearchSeattle, Washington  98108
Southwest Washington Medical CenterVancouver, Washington  98664