A Phase I/II Study of RAD001 and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
Phase I is intended to determine the maximum tolerated dose. Study drug will be administered
orally, once a day, for 15 days, one day prior to initiation of WBRT at 5 or 10 mg/day
during the phase I component. One of these doses will be selected as the maximum tolerable
dose and will be selected for the phase II component.
- To determine the maximum-tolerated dose of everolimus when combined concurrently with
whole-brain radiotherapy in patients with brain metastasis from stage IV non-small cell
lung cancer. (Phase I)
- To evaluate the median survival of these patients treated with this regimen. (Phase II)
- To assess the response rates in these patients. (Phase II)
- To assess the safety and tolerability of this regimen in these patients. (Phase II)
- To determine time to CNS (neurological) progression, confirmed by MRI, in these
patients. (Phase II)
- To determine time to systemic (non-CNS) progression in these patients. (Phase II)
OUTLINE: This is a multicenter, dose-escalation study of everolimus.
Patients undergo 10 fractions of whole-brain radiotherapy (WBRT) beginning on day 0, 5 days
per week, and receive oral everolimus once daily on days -1 to 13. Beginning 2 weeks after
completion of WBRT, patients receive oral everolimus once daily for 28 days in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Safety is measured by the rate of ≥ grade 3 hematological and non-hematologic study-related toxicities.
4 week DLT period
Vicki Keedy, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC THO 0772
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|