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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Mouth Diseases, Mouth Ulcers, Oral Mucositis, Head and Neck Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Steve Sonis, DMD DMSc

Investigator Role:

Study Director

Investigator Affiliation:

Harvard, Oral Medicine, Infection & Immunology

Authority:

United States: Food and Drug Administration

Study ID:

RK:0202-02

NCT ID:

NCT00230191

Start Date:

January 2003

Completion Date:

December 2005

Related Keywords:

  • Mouth Diseases
  • Mouth Ulcers
  • Oral Mucositis
  • Head and Neck Cancer
  • Oral
  • Mucositis
  • Stomatitis
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Mouth Diseases
  • Stomatitis
  • Ulcer
  • Oral Ulcer
  • Mucositis

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
UCLA Medical CenterLos Angeles, California  90095-7059
H Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Commonwealth ENTLouisville, Kentucky  40207
University of ConnecticuttFarmington, Massachusetts  06030
Medical University of Ohio, Cancer Institute Ruppert Cancer CenterToledo, Ohio  43614