Alliance A221701

Clinical Trial Title Phase III placebo-controlled trial to evaluate dexamethasone use for everolimus-induced oral stomatitis: prevention versus early treatment approaches
Trial Status Closed to Enrollment
Start Date 02/15/2019
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition
Description This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.
Eligibility Criteria

Eligibility 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.
  • Prior Treatment
  •     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.
  • ECOG Performance Status 0, 1 or 2.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Principal Investigator Regan Look, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail