RATIONALE: RK-0202 may be able to prevent oral mucositis in patients who are undergoing radiation therapy for cancer of the mouth, throat, or salivary glands.

PURPOSE: Randomized phase II trial to study the effectiveness of RK-0202 in preventing inflammation of the mouth in patients who are undergoing radiation therapy for cancer of the mouth, throat, or salivary glands.

Condition	Treatment or Intervention	Phase
lip and oral cavity cancer Nasopharyngeal Cancer oral complications of cancer and cancer therapy Oropharyngeal Cancer radiation toxicity Salivary Gland Cancer	Drug: RK-0202  Procedure: complications of therapy assessment/management  Procedure: radioprotection  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES:

• 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.
• Determine the safety and tolerability of this drug in these patients.
• Compare the effect of placebo mouthwash vs standard care in these patients.

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.

PROJECTED ACCRUAL: 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 cm
• 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

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

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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting

Study chairs or principal investigators

Guy J.F. Juillard, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000257185; UCLA-0205011; NCI-G02-2111; RK-0202:02; NCT00046956
Record last reviewed:  November 2003
Last Updated:  December 6, 2004
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00046956
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08