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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00574860
• Other study ID #: EN3285-301
• Status: Terminated
• Phase: Phase 3
• First received: December 14, 2007
• Last updated: September 17, 2013
• Start date: December 2007
• Est. completion date: June 2009

Study information

• Verified date: September 2013
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• EN3285
Oral rinse
• Placebo
Oral rinse

Other:
• Standard of care
This will be the therapy most commonly used the the institution treating the patient

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Commonwealth ENT	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NCI v3 to measure severity of OM		At 50 Gy	No
Secondary	WHO criteria for measuring severity of OM		At 50 Gy	No