Safety and Efficacy of RK0202 in Oral Mucositis

Tracking Information
First Submitted Date ICMJE	September 28, 2005
First Posted Date ICMJE	September 30, 2005
Last Update Posted Date	January 15, 2007
Study Start Date ICMJE	January 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 28, 2005)	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; (submitted: September 28, 2005)	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; 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; (submitted: September 28, 2005)	110
Original Enrollment ICMJE	Same as current
Study 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, Older Adult)
Accepts Healthy Volunteers	No
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
IPD Sharing Statement	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