Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer

PRIMARY OBJECTIVES:

I. To determine if the initiation of dexamethasone at the start of everolimus treatment
prevents mTOR inhibitor-associated stomatitis (mIAS)-associated pain, compared to the
initiation of placebo.

II. To determine if the initiation of dexamethasone at the start of everolimus treatment will
be superior compared to the initiation of placebo in terms of the overall severity of
mIAS-associated pain.

SECONDARY OBJECTIVES:

I. To utilize the same measurement method that was reported in the SWISH trial: A combination
of a patient reported pain scale, data from a normalcy of diet questionnaire, and clinician
grading of stomatitis to determine the incidence of > grade 2 mIAS.

II. To determine if the initiation of dexamethasone at the start of everolimus increases time
to development of mouth pain using daily numerical analog scale patient-reported data
collection.

III. To assess if quality of life is better when dexamethasone mouth rinse use starts at the
same time as everolimus use versus at the time when mouth pain begins.

IV. To investigate if starting dexamethasone mouth rinse concurrent with starting everolimus
improves patients' ability to adhere to everolimus therapy.

V. To compare dexamethasone prescription fill rates and timing between patients who received
placebo versus study drug at the initiation of everolimus.

Trial Design:

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive everolimus orally (PO) once daily (QD) as standard of care and
dexamethasone as mouthwash over 2 minutes 4 times per day (QID) for 8 weeks.

GROUP II: Patients receive everolimus PO QD as standard of care and placebo as mouthwash over
2 minutes QID for 8 weeks.

Inclusion Criteria:

- Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without
an endocrine agent. Patients about to receive everolimus for off label use for any
cancer are also eligible.

- Not currently receiving chemotherapy or any other agent known to cause mucositis or
stomatitis. Trastuzumab and ovarian function suppression are allowed.

- Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed
at least 2 weeks prior to registration.

- Not currently suffering from stomatitis/mucositis or mouth ulcers. Patients should not
have had any stomatitis or mouth pain for at least 7 days prior to registration.

- Patients should not receive any other agent which would be considered treatment for
stomatitis or impact the primary endpoint.

- No history of candida infection (thrush) within the last 3 months.

- Not currently being treated with corticosteroids.

- No uncontrolled diabetes mellitus, defined by hemoglobin A1C greater than 8%, although
A1C is not needed for all patients, hemoglobin (Hgb)A1C < 8 is required for everyone
with diabetes or suspected diabetes.

- Patients must be able to read and comprehend English. Local translation, including
verbal translation of professionals (PROs) is not permitted.

- Not pregnant and not nursing, because this study involves an investigational agent
whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn
are unknown. Therefore, for women of childbearing potential only, a negative pregnancy
test done =< 7 days prior to registration is required.

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.