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- Title
A Phase I/II study of strontium-89 combined with gemcitabine in the treatment of patients with androgen independent prostate carcinoma and bone metastases.
- Authors
Lance C. Pagliaro; Ebrahim S. Delpassand; Dallas Williams; Randall E. Millikan; Shi-Ming Tu; Christopher J. Logothetis
- Abstract
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. 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. Fifteen patients were registered, and all were assessable for response and toxicity. Four patients were treated at Dose Level 1 (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 25,00050,000 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. 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. Cancer 2003;97:298894. © 2003 American Cancer Society. DOI 10.1002/cncr.11412
- Subjects
PROSTATE cancer; CANCER patients; ANDROGENS; BONE metastasis; DRUG dosage
- Publication
Cancer (0008543X), 2003, Vol 97, Issue 12, p2988
- ISSN
0008-543X
- Publication type
Article