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| Sponsored by: |
Daiichi Sankyo Inc. |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017511 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Oral Complications Radiation Toxicity |
Drug: cevimeline hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | 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: | June 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 280 patients (140 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 71 Study Locations| Study Chair: | Robert Vitti, MD | Daiichi Sankyo Inc. |
More Information
| Study ID Numbers: | CDR0000068698, DAIICHI-2011A-PRT003/004, UCLA-0104045 |
| Study First Received: | June 6, 2001 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017511 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Neurotransmitter Agents Nasopharyngeal Carcinoma Laryngeal Carcinoma Carcinoma, Basal Cell Cholinergic Agents Granuloma Squamous Cell Carcinoma Xerostomia Recurrence Hypopharyngeal Cancer Carcinoma |
Metastatic Squamous Neck Cancer With Occult Primary Carcinoma, Adenoid Cystic Cevimeline Head and Neck Neoplasms Epidermoid Carcinoma Neoplasm Metastasis Peripheral Nervous System Agents Adenoid Cystic Carcinoma Carcinoma, Squamous Cell Papilloma Salivary Gland Diseases |
|
Parasympathomimetics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Cevimeline Autonomic Agents Head and Neck Neoplasms Muscarinic Agonists Peripheral Nervous System Agents |