EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer
This study has been terminated.
(Additional research)
Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00574860
First received: December 14, 2007
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Oral Mucositis Head and Neck Cancer |
Drug: EN3285 Drug: Placebo Other: Standard of care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Endo Pharmaceuticals:
Primary Outcome Measures:
- NCI v3 to measure severity of OM [ Time Frame: At 50 Gy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- WHO criteria for measuring severity of OM [ Time Frame: At 50 Gy ] [ Designated as safety issue: No ]
| Enrollment: | 240 |
| Study Start Date: | December 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EN3285 (NAC ProGelz)
The EN3285 arm is the product under development
|
Drug: EN3285
Oral rinse
|
|
Placebo Comparator: No active ingredients (placebo)
This will be an oral product that contains no active ingredient
|
Drug: Placebo
Oral rinse
|
|
Standard of Care
This arm will reflect the typical standard of care for the patient
|
Other: Standard of care
This will be the therapy most commonly used the the institution treating the patient
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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,
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574860
Locations
| United States, Kentucky | |
| Commonwealth ENT | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
| Principal Investigator: | Mark Chambers, MD | M.D. Anderson Cancer Center |
More Information
No publications provided
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00574860 History of Changes |
| Other Study ID Numbers: | EN3285-301 |
| Study First Received: | December 14, 2007 |
| Last Updated: | September 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endo Pharmaceuticals:
|
Oral Mucositis Chemoradiation therapy Head and neck cancer |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Stomatitis Mucositis Neoplasms by Site Neoplasms |
Mouth Diseases Stomatognathic Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013