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Phase I study of samarium-153 lexidronam with docetaxel in castration-resistant metastatic prostate cancer.


ABSTRACT: Early studies of patients with castration-resistant metastatic prostate cancer (CRMPC) suggest that chemotherapy administered with a dose of a bone-seeking radiopharmaceutical is superior to chemotherapy alone. To build on this strategy and fully integrate a repetitively dosed bone-seeking radiopharmaceutical into a contemporary chemotherapy regimen, we conducted a phase I study of docetaxel and samarium-153 ((153)Sm) lexidronam.Men with progressive CRMPC were eligible. Cohorts of three to six patients were defined by dose escalations as follows: docetaxel 65, 70, 75, 75, 75 mg/m(2) and (153)Sm ethylenediaminetetramethylenephosphonate (EDTMP) 0.5, 0.5, 0.5, 0.75, 1 mCi/kg. Each cycle lasted a minimum of 6 (cohorts 1 through 5) or 9 (cohort 6) weeks. Docetaxel was administered on days 1 and 22 (and day 43 for cohort 6), and (153)Sm-EDTMP was administered on day -1 to 1 of each cycle. Patients with acceptable hematologic toxicities were eligible to receive additional cycles until progression.Twenty-eight men were treated in six cohorts. Maximum-tolerated dose was not reached, because full doses of both agents were well tolerated, even using an every-6-week dosing schedule of (153)Sm-EDTMP. Patients received an average of 5.6 docetaxel doses (range, one to 13 doses) and 2.9 (153)Sm-EDTMP doses (range, one to six doses). Fifteen patients demonstrated a more than 50% decline in prostate-specific antigen. Treatment significantly reduced indices of bone deposition and resorption.Docetaxel and (153)Sm-EDTMP can be combined safely at full doses over repeated cycles. Responses were seen in the small group of patients with taxane-resistant disease tested. The optimal phase II doses for patients with taxane-naïve disease may differ from those optimal for patients with taxane-resistant disease.

SUBMITTER: Morris MJ 

PROVIDER: S-EPMC2684850 | biostudies-literature | 2009 May

REPOSITORIES: biostudies-literature

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Phase I study of samarium-153 lexidronam with docetaxel in castration-resistant metastatic prostate cancer.

Morris Michael J MJ   Pandit-Taskar Neeta N   Carrasquillo Jorge J   Divgi Chaitanya R CR   Slovin Susan S   Kelly William K WK   Rathkopf Dana D   Gignac Gretchen A GA   Solit David D   Schwartz Lawrence L   Stephenson Ryan D RD   Hong Christina C   Delacruz Anthony A   Curley Tracy T   Heller Glenn G   Jia Xiaoyu X   O'Donoghue Joseph J   Larson Steven S   Scher Howard I HI  

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20090413 15


<h4>Purpose</h4>Early studies of patients with castration-resistant metastatic prostate cancer (CRMPC) suggest that chemotherapy administered with a dose of a bone-seeking radiopharmaceutical is superior to chemotherapy alone. To build on this strategy and fully integrate a repetitively dosed bone-seeking radiopharmaceutical into a contemporary chemotherapy regimen, we conducted a phase I study of docetaxel and samarium-153 ((153)Sm) lexidronam.<h4>Patients and methods</h4>Men with progressive C  ...[more]

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