Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
Status:
Terminated
Trial end date:
2013-04-11
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to determine the safety of giving ketoconazole,
hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose
limiting toxicity (DLT) evaluation at various dose levels (DL). The investigators believe
that there is evidence in castrate resistant prostate cancer (CRPC) that two growth factor
receptors (EGFR and Her 2/Neu) are increased in prostate cancer (PCa) cells. Both these
receptors are turned off by the drug lapatinib. By adding lapatinib, the investigators hope
that signaling from the receptors will be turned off and therefore make the participant's
cancer more responsive to KHAD treatment.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Beth Israel Deaconess Medical Center Dana-Farber Cancer Institute
Collaborators:
Beth Israel Deaconess Medical Center Brigham and Women's Hospital Dana-Farber Cancer Institute GlaxoSmithKline Massachusetts General Hospital Prostate Cancer Foundation Clinical Research Consortium