Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Prostate Cancer
Interventions
OTHER

Everolimus, lupron, bicalutamide, and radiation

"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 15 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."

Trial Locations (2)

20057

Georgetown University, Washington D.C.

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

University of Michigan Rogel Cancer Center

OTHER