Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer
The principal objective of this trial is to evaluate the safety, feasibility, and anti-tumor
effects of a novel bone-targeted regimen consisting of Samarium Sm-153 lexidronam combined
with docetaxel and prednisone. This present study design permits evaluation of the clinical
activity of combining two distinct agents that have shown benefit for the treatment of
patients with advanced androgen-independent prostate cancer and bone metastases. It enables
assessment of potential synergistic interactions between a cytotoxic chemotherapy agent and
a bone-targeting radioisotope agent in the setting of a bone-targeted therapy.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome is safety and tolerability of the combination treatment
Michael J Morris, M.D.
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|