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

This study has been terminated.
(Additional research)
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00574860
First received: December 14, 2007
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

Randomized, double-blind, placebo-controlled study 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).


Condition Intervention Phase
Oral Mucositis
Head and Neck Cancer
Drug: EN3285
Drug: Placebo
Other: Standard of care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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:


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 ]

Enrollment: 240
Study Start Date: December 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EN3285 (NAC ProGelz)
The EN3285 arm is the product under development
Drug: EN3285
Oral rinse
Placebo Comparator: No active ingredients (placebo)
This will be an oral product that contains no active ingredient
Drug: Placebo
Oral rinse
Standard of Care
This arm will reflect the typical standard of care for the patient
Other: Standard of care
This will be the therapy most commonly used the the institution treating the patient

Detailed Description:

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Kentucky
Commonwealth ENT
Louisville, Kentucky, United States, 40207
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
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
ClinicalTrials.gov Identifier: NCT00574860     History of Changes
Other Study ID Numbers: EN3285-301
Study First Received: December 14, 2007
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Oral Mucositis
Chemoradiation therapy
Head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 01, 2014