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
18 Years
N/A
Both
Oral Mucositis, Head and Neck Cancer
Trial Information
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
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).
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,
Type of Study:
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
Outcome Measure:
NCI v3 to measure severity of OM
Outcome Time Frame:
At 50 Gy
Safety Issue:
No
Principal Investigator
Mark Chambers, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
EN3285-301
NCT ID:
NCT00574860
Start Date:
December 2007
Completion Date:
June 2009
Related Keywords:
- Oral Mucositis
- Head and Neck Cancer
- Oral Mucositis
- Chemoradiation therapy
- Head and neck cancer
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Commonwealth ENT | Louisville, Kentucky 40207 |
