Clinical trial NCT00574860: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Oral Mucositis
Head and Neck Cancer
Keywords: Oral Mucositis
Chemoradiation therapy
Head and neck cancer
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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,

Primary outcomes:
measure: NCI v3 to measure severity of OM
timeFrame: At 50 Gy
Secondary outcomes:
measure: WHO criteria for measuring severity of OM
timeFrame: At 50 Gy
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Commonwealth ENT
state: Kentucky
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Mark Chambers, MD
role: PRINCIPAL_INVESTIGATOR
References: