TY - JOUR
T1 - A phase I/II study of strontium-89 combined with gemcitabine in the treatment of patients with androgen independent prostate carcinoma and bone metastases
AU - Pagliaro, Lance C.
AU - Delpassand, Ebrahim S.
AU - Williams, Dallas
AU - Millikan, Randall E.
AU - Tu, Shi Ming
AU - Logothetis, Christopher J.
PY - 2003/6/15
Y1 - 2003/6/15
N2 - BACKGROUND. The objectives of the current study were to determine the maximum tolerated dose and to evaluate the efficacy of gemcitabine given in combination with strontium-89 to patients with androgen independent prostate carcinoma. METHODS. Patients with androgen-independent prostate carcinoma and painful osteoblastic bone metastases were eligible. On a 12-week course, patients received gemcitabine (600 mg/m2 or 800 mg/m2) on Days 1, 8, 15, 43, 50, and 57. A single dose of strontium-89 (55 μCi/kg) was administered on Day 8. RESULTS. Fifteen patients were registered, and all were assessable for response and toxicity. Four patients were treated at Dose Level I (gemcitabine 600 mg/m2) without dose-limiting toxicity. Eleven patients received a total of 13 courses at Dose Level 2 (gemcitabine 800 mg/m2). Platelet nadirs of 25,000-50,000 platelets per μL were common at Dose Level 2, and 1 patient had Grade 4 thrombocytopenia that was dose-limiting. Granulocyte nadirs up to < 500 granulocytes per μL occurred in 4 patients at Dose Level 2 and were reversible. There were no responses, as measured by prostate specific antigen concentration, although 6 patients (40%) had stable disease. CONCLUSIONS. The authors concluded that 800 mg/m2 gemcitabine was the maximum tolerated dose for the combination. The study was terminated on the basis that an overall response rate > than 10% was unlikely. Further study at this dose level and schedule is not warranted.
AB - BACKGROUND. The objectives of the current study were to determine the maximum tolerated dose and to evaluate the efficacy of gemcitabine given in combination with strontium-89 to patients with androgen independent prostate carcinoma. METHODS. Patients with androgen-independent prostate carcinoma and painful osteoblastic bone metastases were eligible. On a 12-week course, patients received gemcitabine (600 mg/m2 or 800 mg/m2) on Days 1, 8, 15, 43, 50, and 57. A single dose of strontium-89 (55 μCi/kg) was administered on Day 8. RESULTS. Fifteen patients were registered, and all were assessable for response and toxicity. Four patients were treated at Dose Level I (gemcitabine 600 mg/m2) without dose-limiting toxicity. Eleven patients received a total of 13 courses at Dose Level 2 (gemcitabine 800 mg/m2). Platelet nadirs of 25,000-50,000 platelets per μL were common at Dose Level 2, and 1 patient had Grade 4 thrombocytopenia that was dose-limiting. Granulocyte nadirs up to < 500 granulocytes per μL occurred in 4 patients at Dose Level 2 and were reversible. There were no responses, as measured by prostate specific antigen concentration, although 6 patients (40%) had stable disease. CONCLUSIONS. The authors concluded that 800 mg/m2 gemcitabine was the maximum tolerated dose for the combination. The study was terminated on the basis that an overall response rate > than 10% was unlikely. Further study at this dose level and schedule is not warranted.
KW - Bone-targeted therapy
KW - Gemcitabine
KW - Metastatic prostate carcinoma
KW - Phase I clinical trial
KW - Phase II clinical trial
KW - Strontium-89
UR - http://www.scopus.com/inward/record.url?scp=0037672705&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0037672705&partnerID=8YFLogxK
U2 - 10.1002/cncr.11412
DO - 10.1002/cncr.11412
M3 - Article
C2 - 12784333
AN - SCOPUS:0037672705
SN - 0008-543X
VL - 97
SP - 2988
EP - 2994
JO - Cancer
JF - Cancer
IS - 12
ER -