PMID: 16613662Apr 15, 2006Paper

Randomized, double-blind, phase II trial of gallium nitrate compared with pamidronate for acute control of cancer-related hypercalcemia

The Cancer Journal
Frédérique CvitkovicR P Warrell

Abstract

Both gallium nitrate and pamidronate are highly effective for acute control of cancer-related hypercalcemia. However, the proportion of patients who actually achieve normocalcemia has varied in published reports. Therefore, we conducted an exploratory, randomized, double-blind trial that compared the efficacy and safety of gallium nitrate and pamidronate in hospitalized patients with cancer-related hypercalcemia. Eligible patients with hypercalcemia, defined as albumin-adjusted serum calcium > or = 12.0 mg/dL after intravenous hydration, were stratified on the basis of tumor histology (i.e., epidermoid or nonepidermoid) and by study site. Patients were then randomly assigned to receive intravenous gallium nitrate 200 mg/m2 daily for 5 days or intravenous pamidronate 60 mg (increased during the study to 90 mg for patients with initial serum calcium > or = 13.5 mg/dL) followed by placebo infusions for 4 days. The primary endpoint of the study was comparison of the proportion of patients who achieved normocalcemia. Sixty-four patients were randomized, and all patients were evaluable for efficacy and safety. Normocalcemia was achieved in 22 of 32 (69%) patients treated with gallium nitrate compared with 18 of 32 patients (56%) trea...Continue Reading

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