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

NCT ID: NCT00574860

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-06-30

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).

Conditions

Oral Mucositis; Head and Neck Cancer

Keywords

Oral Mucositis; Chemoradiation therapy; Head and neck cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

EN3285 (NAC ProGelz)

The EN3285 arm is the product under development

Group Type: EXPERIMENTAL

EN3285

Intervention Type: DRUG

Oral rinse

No active ingredients (placebo)

This will be an oral product that contains no active ingredient

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral rinse

Standard of Care

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

Group Type: OTHER

Standard of care

Intervention Type: OTHER

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

Interventions

EN3285

Oral rinse

Intervention Type: DRUG

Placebo

Oral rinse

Intervention Type: DRUG

Standard of care

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

Intervention Type: OTHER

Eligibility Criteria

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

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Chambers, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Commonwealth ENT

Louisville, Kentucky, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

EN3285-301

Identifier Type: -

Identifier Source: org_study_id