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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00017511
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE June 6, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date May 16, 2012
Study Start Date  ICMJE June 2001
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00017511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Official Title  ICMJE 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
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Supportive Care
Condition  ICMJE
  • Head and Neck Cancer
  • Oral Complications
  • Radiation Toxicity
Intervention  ICMJE Drug: cevimeline hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00017511
Other Study ID Numbers  ICMJE CDR0000068698
DAIICHI-2011A-PRT003/004
UCLA-0104045
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert Vitti, MD Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP