Safety and Efficacy of RK0202 in Oral Mucositis

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230191
• Other study ID #: RK:0202-02
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2005
• Last updated: January 12, 2007
• Start date: January 2003
• Est. completion date: December 2005

Study information

• Verified date: October 2005
• Source: RxKinetix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00046956

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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-ß (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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mouth Diseases
• Mouth Ulcers
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• RK-0202

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Center	Hamilton	Ontario
Canada	University of Ottawa	Ottawa	Ontario
United States	University of Connecticutt	Farmington	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas
United States	UCLA Medical Center	Los Angeles	California
United States	Commonwealth ENT	Louisville	Kentucky
United States	H Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Medical University of Ohio, Cancer Institute Ruppert Cancer Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
RxKinetix

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.