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

Primary Purpose

Oral Mucositis, Head and Neck Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
EN3285
Placebo
Standard of care
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring Oral Mucositis, Chemoradiation therapy, Head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Commonwealth ENT
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

EN3285 (NAC ProGelz)

No active ingredients (placebo)

Standard of Care

Arm Description

The EN3285 arm is the product under development

This will be an oral product that contains no active ingredient

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

Outcomes

Primary Outcome Measures

NCI v3 to measure severity of OM

Secondary Outcome Measures

WHO criteria for measuring severity of OM

Full Information

First Posted
December 14, 2007
Last Updated
September 17, 2013
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00574860
Brief Title
EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Additional research
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, Head and Neck Cancer
Keywords
Oral Mucositis, Chemoradiation therapy, Head and neck cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EN3285 (NAC ProGelz)
Arm Type
Experimental
Arm Description
The EN3285 arm is the product under development
Arm Title
No active ingredients (placebo)
Arm Type
Placebo Comparator
Arm Description
This will be an oral product that contains no active ingredient
Arm Title
Standard of Care
Arm Type
Other
Arm Description
This arm will reflect the typical standard of care for the patient
Intervention Type
Drug
Intervention Name(s)
EN3285
Intervention Description
Oral rinse
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral rinse
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
This will be the therapy most commonly used the the institution treating the patient
Primary Outcome Measure Information:
Title
NCI v3 to measure severity of OM
Time Frame
At 50 Gy
Secondary Outcome Measure Information:
Title
WHO criteria for measuring severity of OM
Time Frame
At 50 Gy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Chambers, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Commonwealth ENT
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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