The clinical study will evaluate the safety profile and preliminary incidence and duration of clinical benefits of novel escalating dose and administration schedules of Taxotere in combination with multiple doses of Quadramet. The dosing schedules to be investigated are based on data from preclinical research carried out at Johns Hopkins.
“Current clinical and preclinical data suggest that a bone targeted approach may represent a potentially useful added component for the treatment of metastatic prostate cancer,” commented Dr Mario Eisenberger, professor of oncology and urology at the Johns Hopkins Kimmel Cancer Center. “This trial represents a preliminary evaluation of the safety when combining Quadramet with docetaxel and may also provide important preliminary efficacy information.”
Quadramet pairs the targeting ability of a small molecule, bone-seeking phosphonate (EDTMP) with the therapeutic potential of radiation (samarium Sm-153). Combined, these agents form an innovative molecule with a short radioactive half-life that selectively concentrates in areas of new bone formation.
Taxotere inhibits cancer cell division by essentially “freezing” the cell’s internal skeleton, which is comprised of microtubules. Taxotere also exhibits potent radiosensitizing capability that may be synergistic with Quadramet. For this reason, current and planned trials are exploring the optimal dose and schedule of administration of Taxotere with concurrent Quadramet radiotherapy.