Safety and Efficacy of RK0202 in Oral Mucositis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Mouth Diseases Mouth Ulcers Oral Mucositis Head and Neck Cancer	Drug: RK-0202	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Mouth Disorders

U.S. FDA Resources

Further study details as provided by RxKinetix:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	110
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230191

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00230191 History of Changes
Obsolete Identifiers:	NCT00046956
Other Study ID Numbers:	RK:0202-02
Study First Received:	September 28, 2005
Last Updated:	January 12, 2007
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by RxKinetix:

Oral
Mucositis
Stomatitis
Head and Neck Cancer

Additional relevant MeSH terms:

Head and Neck Neoplasms
Mouth Diseases
Stomatitis
Ulcer
Oral Ulcer
Mucositis
Neoplasms by Site

Neoplasms
Stomatognathic Diseases
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013