Phase I/II study of docetaxel and 153Sm for castrate metastatic prostate cancer (CMPC): Summary of dose-escalation cohorts and first report on the expansion cohort

5057 Background: We previously reported (ASCO 2008) that full doses of docetaxel (Tax) and Sm can be repetitively delivered safely using a schedule of q 3 week (wk) Tax and q 6–9 wk Sm. Here we summarize the dose-escalation cohorts and safety/efficacy data from the expansion cohort of 24 pts. Methods: Cohorts of 3–6 pts with CPMC were defined by: 65, 70, 75, 75, 75 mg/m2 of Tax and Sam 0.5, 0.5, 0.5, 0.75, 1 mCi/kg. Each cycle was 6 wks. The expansion cohort used 75 mg/m2 Tax (q 3 wk) and 1 mCi/kg Sm (q 9 wk). Pts with an ANC of grade 0–1 and platelet count of > 100,000/mm3 at the end of cycle 1 received additional cycles until progression or toxicity. Results: 52 pts have been treated. 28 pts were taxane naive, 11 received previous taxanes but were not refractory, and 13 were taxane refractory. As anticipated, side effects were primarily hematologic. However, the leading cause for treatment termination was disease progression, involving 16/52 (31%) pts, rather than toxicity. 12/52 (23%) pts came off for ...