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A Phase I/II study of strontium-89 combined with gemcitabine in the treatment of patients with androgen independent prostate carcinoma and bone metastases.

AbstractBACKGROUND:
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.
AuthorsLance C Pagliaro, Ebrahim S Delpassand, Dallas Williams, Randall E Millikan, Shi-Ming Tu, Christopher J Logothetis
JournalCancer (Cancer) Vol. 97 Issue 12 Pg. 2988-94 (Jun 15 2003) ISSN: 0008-543X [Print] United States
PMID12784333 (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.)
CopyrightCopyright 2003 American Cancer Society.
Chemical References
  • Radiation-Sensitizing Agents
  • Strontium Radioisotopes
  • Deoxycytidine
  • Testosterone
  • Prostate-Specific Antigen
  • strontium chloride
  • Strontium
  • Gemcitabine
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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