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

NCT00574860 | Terminated Phase 3 DMC

• 1 other identifier: EN3285-301
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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).

Conditions

Oral Mucositis; Head and Neck Cancer

Keywords

Oral Mucositis; Chemoradiation therapy; Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• NCI v3 to measure severity of OM

  At 50 Gy

Secondary Outcomes (1)

• WHO criteria for measuring severity of OM

  At 50 Gy

Study Arms (3)

EN3285 (NAC ProGelz)

EXPERIMENTAL

The EN3285 arm is the product under development

Drug: EN3285

No active ingredients (placebo)

PLACEBO COMPARATOR

This will be an oral product that contains no active ingredient

Drug: Placebo

Standard of Care

OTHER

This arm will reflect the typical standard of care for the patient

Other: Standard of care

Interventions

EN3285 DRUG

Oral rinse

EN3285 (NAC ProGelz)

Placebo DRUG

Oral rinse

No active ingredients (placebo)

Standard of care OTHER

This will be the therapy most commonly used the the institution treating the patient

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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,

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (2)

Commonwealth ENT

Louisville, Kentucky, 40207, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mark Chambers, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: December 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 20, 2013

Record last verified: 2013-09

Locations

US (2)