Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Closed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0205011 NCI-G02-2111, RK-0202:02, NCT00046956

Objectives

1. Compare the efficacy of 2 different doses of RK-0202 rinse on incidence, severity, and time to onset of oral mucositis in patients with tumors of the oral cavity, oropharynx, nasopharynx, salivary glands, or supraglottic region who are undergoing radiotherapy.
2. Determine the safety and tolerability of this drug in these patients.
3. Compare the effect of placebo mouthwash vs standard care in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed tumors of the oral cavity, oropharynx, nasopharynx, salivary glands, or supraglottic region



• Planned radiotherapy that would deliver a minimum of 60 Gy over 5-8 weeks to at least 2 cm² of 3 or more of the following oral cavity anatomical sites:
  • Upper or lower lip
  • Right or left buccal
  • Right or left lateral/ventral tongue
  • Right or left dorsal tongue
  • Right or left floor of mouth
  • Right or left soft palate
  • Right or left tonsil region
  • Right or left hard palate
  • Nasopharynx



• Radiotherapy must begin within 9 weeks after prior surgery and regimens may comprise the following:
  • Single-dose daily fractionated regimen (daily maximum of 2.2 Gy)
  • Hyperfractionated regimen (daily maximum of 2.4 Gy)
  • Concurrent boost (daily maximum of 3.3 Gy during boost)



• No oral mucositis present



• No T1 or T2 glottic tumors

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy to the head and neck
• No concurrent brachytherapy or interstitial implantation

Surgery

• See Disease Characteristics

Other

• At least 14 days since prior investigational drugs
• No topical or oral medications for 30 minutes before and after study drug administration
• No concurrent amifostine
• No other concurrent investigational drugs
• No other concurrent investigational or mucoprotective therapy for the prevention of oral mucositis including, but not limited to the following:
  • Beta-carotene
  • Tocopherol
  • Laser irradiation
  • Brushing the oral mucosa with silver nitrate prophylactically
  • Systemic transforming growth factor-beta
  • Misoprostol
  • Pentoxifylline
  • Leucovorin calcium
  • Allopurinol mouthwashes
  • Systemic keratinocyte growth factor
  • Pilocarpine
• No concurrent oral rinses with hydrogen peroxide, sucralfate, or chlorhexidine gluconate

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No serious recent nonmalignant medical condition that would preclude study participation
• No medical, sociological, or psychological impediment that would preclude study participation
• No eating for 30 minutes before and after study drug administration
• Able to undergo oral assessments

Expected Enrollment

A total of 105 patients (30 in each active drug arm, 30 in the placebo arm, and 15 in the standard care arm) will be accrued for this study within 1 year.

Outcomes

Area under the curve (AUC) for the mean Oral Mucositis Assessment Scale (OMAS) scores over cumulative radiotherapy (RT) dose

AUC for the mean OMAS anatomic sites over cumulative RT dose
Distribution of mean mucositis scores over equal sequential intervals of radiation
Time to onset of mucositis by OMAS, WHO, and NCI
Mean and peak scores and extent of ulceration-number of anatomic sites at each evaluation with an OMAS ulceration score of 3
Proportion of patients with none-to-mild or moderate-to-severe mucositis at each specified interval of RT
Oral symptomatic assessment
Analgesic use
Intent to treat analyses of efficacy and safety data
Safety and tolerability

Outline

This is a randomized, placebo-controlled, double-blind, parallel-group, multicenter study. Patients are randomized to 1 of 4 arms.

• Arm I: Patients receive oral RK-0202 mouthwash for 1 minute (gargle for 5 seconds) and then expectorate. RK-0202 is administered 6 times daily, with at least 1 dose administered 30 minutes before each radiotherapy treatment.



• Arm II: Patients receive a different dose of RK-0202 administered as in arm I.



• Arm III: Patients receive placebo mouthwash, which is administered on the same schedule as in arm I.



• Arm IV: Patients receive standard care.

Treatment in all arms begins on the first day of radiotherapy and continues until radiotherapy is completed.

Patients are followed at 30 days and then at 3 and 12 months.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Guy Juillard, MD, Principal investigator		Ph: 310-825-7145; 888-798-0719

Registry Information
Official Title		A 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
Trial Start Date		2002-08-13
Registered in ClinicalTrials.gov		NCT00046956
Date Submitted to PDQ		2002-08-08
Information Last Verified		2006-01-25
NCI Grant/Contract Number		P30-CA16042

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