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

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00017511
• Collaborator: (none)
• Locations: 71
• Duration (Months): 21

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Oral Complications; Radiation Toxicity	Drug: cevimeline hydrochloride	Phase 3

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 Design

• Study Type: Interventional
• Primary Purpose: Supportive Care
• 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
• Study Start Date: Jun 1, 2001
• Actual Primary Completion Date: Mar 1, 2003
• Actual Study Completion Date: Mar 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT00017511
• Other Study ID Numbers: CDR0000068698; DAIICHI-2011A-PRT003/004; UCLA-0104045
• First Posted: Jan 27, 2003
• Last Update Posted: May 16, 2012
• Last Verified: May 1, 2012

• Keywords provided by Daiichi Sankyo, Inc.: 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
• Additional relevant MeSH terms: Head and Neck Neoplasms; Cevimeline

Study Results

No Results Posted as of May 16, 2012