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

Phase 3

Terminated

• Conditions: Head and Neck Cancer; Oral Mucositis
• Interventions: Other: Standard of care; Drug: EN3285; Drug: Placebo

• Registration Number: NCT00574860
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

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).

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).

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2013-09
• Disposition First Submitted: 2013-09-09
• Disposition First Submitted QC: 2013-09-17
• Last Update Submitted: 2013-09-17
• Disposition First Posted: 2013-09-20
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 240

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of care	This arm will reflect the typical standard of care for the patient
EN3285 (NAC ProGelz)	EN3285	The EN3285 arm is the product under development
No active ingredients (placebo)	Placebo	This will be an oral product that contains no active ingredient

Primary Outcome Measures

Name	Time	Method
NCI v3 to measure severity of OM	At 50 Gy

Secondary Outcome Measures

Name	Time	Method
WHO criteria for measuring severity of OM	At 50 Gy

Trial Locations

Locations (2)

Commonwealth ENT; 🇺🇸 Louisville, Kentucky, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States