Safety and Efficacy of RK0202 in Oral Mucositis

This study has been completed.

Sponsor:

Information provided by:

RxKinetix

ClinicalTrials.gov Identifier:

NCT00230191

First received: September 28, 2005

Last updated: January 12, 2007

Last verified: October 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 28, 2005

Last Updated Date

January 12, 2007

Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00230191 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of RK0202 in Oral Mucositis

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Mouth Diseases
Mouth Ulcers
Oral Mucositis
Head and Neck Cancer

Intervention ^ICMJE

Drug: RK-0202

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

110

Estimated Completion Date

December 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00230191

Other Study ID Numbers ^ICMJE

RK:0202-02

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

RxKinetix

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

PRS Account

RxKinetix

Verification Date

October 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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