Abstract | 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/m(2) or 800 mg/m(2)) on Days 1, 8, 15, 43, 50, and 57. A single dose of strontium-89 (55 microCi/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 1 ( gemcitabine 600 mg/m(2)) without dose-limiting toxicity. Eleven patients received a total of 13 courses at Dose Level 2 ( gemcitabine 800 mg/m(2)). Platelet nadirs of 25000-50000 platelets per microL were common at Dose Level 2, and 1 patient had Grade 4 thrombocytopenia that was dose-limiting. Granulocyte nadirs up to < 500 granulocytes per microL 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/m(2) 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.
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Authors | Lance C Pagliaro, Ebrahim S Delpassand, Dallas Williams, Randall E Millikan, Shi-Ming Tu, Christopher J Logothetis |
Journal | Cancer
(Cancer)
Vol. 97
Issue 12
Pg. 2988-94
(Jun 15 2003)
ISSN: 0008-543X [Print] United States |
PMID | 12784333
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Copyright | Copyright 2003 American Cancer Society. |
Chemical References |
- Radiation-Sensitizing Agents
- Strontium Radioisotopes
- Deoxycytidine
- Testosterone
- Prostate-Specific Antigen
- strontium chloride
- Strontium
- Gemcitabine
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Topics |
- Aged
- Bone Neoplasms
(secondary, therapy)
- Carcinoma
(therapy)
- Combined Modality Therapy
- Deoxycytidine
(administration & dosage, analogs & derivatives, therapeutic use, toxicity)
- Drug Administration Schedule
- Humans
- Injections, Intravenous
- Male
- Maximum Tolerated Dose
- Middle Aged
- Neoplasms, Hormone-Dependent
(therapy)
- Prostate-Specific Antigen
(analysis)
- Prostatic Neoplasms
(therapy)
- Radiation-Sensitizing Agents
(therapeutic use)
- Strontium
(therapeutic use)
- Strontium Radioisotopes
(therapeutic use)
- Testosterone
(pharmacology)
- Gemcitabine
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