Phase I study of docetaxel (Tax) and 153Sm repetitively administered for castrate metastatic prostate cancer (CMPC)

5152 Background: Docetaxel (Tax) prolongs survival in patients (pts) with CMPC. Early clinical data suggest that Tax combined with bone seeking radiopharmaceuticals may improve survival relative to chemotherapy alone. 153Sm-lexidronam (Sam) (Quadramet, Cytogen Inc.) is a radiopharmaceutical with a short T1/2 and a favorable toxicity profile. Methods: Pts with progressive CMPC are treated in cohorts of 3–6. Prior treatment with taxanes is permissible. Cohorts are defined by dose escalations of: Tax 65, 70, 75, 75, 75 mg/m2 and Sam 0.5, 0.5, 0.5, 0.75, 1 mCi/kg. Each cycle is 6 weeks. Tax is given day 1 and 22 and Sam day -1 to 1 of each cycle. DLT is defined as cycle 1 = grade 3 non-hematologic toxicity, grade 3 neutropenia that lasts for >29 days, or grade 3- 4 anemia or thrombocytopenia of = 5 days. Pts with an ANC of grade 0–1 or platelet count (PLT) of >100,000/mm3 at the end of cycle 1 may receive additional cycles. Pts are treated until progression or toxicity. Results: 18 pts have been treated in 5 ...