Safety and Efficacy of RK0202 in Oral Mucositis

Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of the Effects of RK-0202 on Oral Mucositis in Patients Receiving Radiation Therapy for Tumors of the Oral Cavity, Oropharynx, Nasopharynx, Salivary Glands or Supraglottic Region

The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis in subjects receiving radiation therapy for head and neck cancer. Concurrent chemotherapy is not allowed in the study.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Mouth Diseases; Oral Mucositis; Mouth Ulcers
• Intervention / Treatment: Drug: RK-0202

Detailed Description

Approximately 42,000 new cases of head and neck squamous cell carcinoma occur annually in the United States. Radiotherapy ("RT") plays a significant role in the management of head and neck cancer. The most common and clinically significant toxicities arising from head and neck radiation therapy are acute mucositis and acute and chronic xerostomia (dry mouth or salivary gland changes). In subjects receiving RT for cancers of the oral cavity or oropharynx the incidence of acute mucositis can exceed 90%. The painful ulceration of the oral mucosa produced by the radiation often leads to the requirement for narcotics to control pain, inability to eat, dehydration, the need for parenteral nutrition and, sometimes, breaks in RT. In addition to its symptomatic cost, the presence of mucositis has been associated with a number of other adverse outcomes including higher costs and more frequent hospitalizations.

• Study Type: Interventional
• Enrollment: 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G1Z2
      • Cross Cancer Institute
  • Ontario
    • Hamilton, Ontario, Canada, L8V5C2
      • Juravinski Cancer Center
    • Ottawa, Ontario, Canada, K1H1C4
      • University of Ottawa
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
  • Florida
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center & Research Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Commonwealth ENT
  • Massachusetts
    • Farmington, Massachusetts, United States, 06030
      • University of Connecticutt
  • Ohio
    • Toledo, Ohio, United States, 43614
      • Medical University of Ohio, Cancer Institute Ruppert Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females 18 years and older with confirmed tumors of the oral cavity, oropharynx, nasopharynx, salivary glands, or supraglottic region who are intended for treatment with RT alone (no concomitant chemotherapy).
• In post-operative patients, RT must begin no later than 9 weeks following surgery.
• Intended for treatment with an RT regimen that will deliver a minimum of 60 Gy over 5-8 weeks to at least 2cm2 of three or more of seventeen protocol-specific oral cavity anatomical sites. Each qualifying site must receive a minimum of 60 Gy and there must be at least three such sites. (See section 5.3.1). Regimens may consist of:
• single dose daily fractionated (daily max 2.2 Gy)
• hyperfractionated (daily max 2.4 Gy)
• concurrent boost (daily max during boost 3.3 Gy)
• The minimum planned duration of treatment must be 5 weeks and the maximum 8 weeks.
• Ability to undergo oral assessments.
• Ability to begin dosing with study drug on day 1 of RT.
• Karnofsky Performance Score > 60.
• Ability to understand the protocol and provide informed consent.
• If female, have negative serum pregnancy test.

Exclusion Criteria:

• Planned use of concomitant chemotherapy.
• Planned use of amifostine.
• Presence of oral mucositis.
• Prior radiotherapy to the head and neck.
• T1 or T2 glottic tumors.
• Other investigational drugs in the 14 days preceding initiation of study medication or during administration of study medication.
• Other investigational or mucoprotective therapy for the prevention of oral mucositis, including, but not limited to, -carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor beta), misoprostol, pentoxifylline, leucovorin, allopurinol mouthwashes, systemic KGF (keratinocyte growth factor) or pilocarpine. Oral rinses with hydrogen peroxide, sucralfate, or chlorhexidine gluconate are also not permitted during the study.
• Serious recent non-malignant medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation.
• Medical, sociological, or psychological impediment to probable compliance with protocol.
• Inability to undergo repeat treatments, clinical evaluations and other diagnostic procedures required by the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis.

Secondary Outcome Measures

Outcome Measure
The secondary objectives of the study are to assess the safety and tolerability of RK-0202 in these subjects and to explore whether the ProGelz™ vehicle alone is active in these subjects.

Collaborators and Investigators

• Sponsor: RxKinetix
• Investigators: Study Director: Steve Sonis, DMD DMSc, Harvard, Oral Medicine, Infection & Immunology; Principal Investigator: Doug Peterson, DMD, University of Connecticutt Health Center; Principal Investigator: Guy Juillard, MD, University of California, Los Angeles; Principal Investigator: Mark Chambers, DMD MS, MD Anderson; Principal Investigator: Andy Trotti, MD, H. Lee Moffitt Cancer Center and Research Institute; Principal Investigator: John Feldmeier, DO, Medical University of Ohio; Principal Investigator: Samy El Sayed, MD, Ottawa Regional Cancer Centre; Principal Investigator: Rufus Scrimger, MD, Cross Cancer Institute, Edmonton, CA; Principal Investigator: Jim Wright, MD, Juravinski Cancer Centre Hamilton Health Sciences; Principal Investigator: Donald Welsh, MD, Commonwealth ENT, Louisville, KY

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion: December 8, 2022
• Study Completion: December 1, 2005

Study Registration Dates

• First Submitted: September 28, 2005
• First Submitted That Met QC Criteria: September 28, 2005
• First Posted (Estimate): September 30, 2005

Study Record Updates

• Last Update Posted (Estimate): January 15, 2007
• Last Update Submitted That Met QC Criteria: January 12, 2007
• Last Verified: October 1, 2005

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Oral; Mucositis; Stomatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Head and Neck Neoplasms; Mucositis; Mouth Diseases; Oral Ulcer; Stomatitis
• Other Study ID Numbers: RK:0202-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No