EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer - Full Text View

Sponsored by:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00574860

Purpose

This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).

Condition	Intervention	Phase
Oral Mucositis Head and Neck Cancer	Drug: EN3285 Drug: Placebo Other: Standard of care	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

NCI v3 to measure severity of OM [ Time Frame: At 50 Gy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

WHO criteria for measuring severity of OM [ Time Frame: At 50 Gy ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: EN3285 Oral rinse
2: Placebo Comparator	Drug: Placebo Oral runse
3	Other: Standard of care Standard of care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Significant Inclusion Criteria:

18 years and older
newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT.
Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx
Chemotherapy: cisplatin
Have a WBC ≥3500 per cubic millimeter
Have a platelet count ≥100,000 per cubic millimeter
Have adequate renal function as determined by the principal investigator prior to enrollment
Are willing and able to undergo oral assessments
Have a Karnofsky Performance Status score ≥70

Significant Exclusion Criteria:

Have OM or other oral conditions at study entry
Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol
Are using a pre-existing feeding tube for nutritional support at study entry
Plan to use any drug for the treatment or prevention of OM
Have had any prior radiotherapy to the head and neck
Have had prior chemotherapy within 6 months preceding enrollment
Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria
Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
Have medical conditions that require the use of chronic steroid therapy
Have the inability to undergo repeat treatments,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574860

Locations

United States, Kentucky
Commonwealth ENT
Louisville, Kentucky, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States

Sponsors and Collaborators

Endo Pharmaceuticals

Investigators

Principal Investigator:

Mark Chambers, MD

M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	Endo Pharmaceuticals ( Endo Pharmaceuticals )
Study ID Numbers:	EN3285-301
Study First Received:	December 14, 2007
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00574860 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

Oral Mucositis
Chemoradiation therapy
Head and neck cancer

Study placed in the following topic categories:

Mouth Diseases
Digestive System Diseases
Stomatitis
Mucositis

Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Mouth Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Stomatitis

Mucositis
Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on September 11, 2009