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

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals

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,