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

Cancer Journal

Volumn 12, Issue 1, 2006, Pages 47-53

  Cvitkovic, Frédérique ^a   Armand, Jean Pierre ^b   Tubiana Hulin, Michèle ^a   Rossi, Jean François ^c   Warrell Jr , Raymond P ^d  

^a CENTRE RENÉ HUGUENIN   (France)

^b INSTITUT GUSTAVE ROUSSY   (France)

^c CENTRE VAL D AURELLE   (France)

^d MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Cancer; Gallium nitrate; Hypercalcemia; Pamidronate

Indexed keywords

CALCIUM; GALLIUM NITRATE; PAMIDRONIC ACID; PHOSPHATE; PLACEBO;

ADULT; ARTICLE; CALCIUM BLOOD LEVEL; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE ASSOCIATION; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; FEMALE; HUMAN; HYPERCALCEMIA; HYPOPHOSPHATEMIA; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SQUAMOUS CELL CARCINOMA; SURVIVAL TIME; TREATMENT DURATION; TREATMENT OUTCOME;

BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; DOUBLE-BLIND METHOD; FEMALE; FLUID THERAPY; GALLIUM; HOSPITALIZATION; HUMANS; HYPERCALCEMIA; MALE; MIDDLE AGED; NEOPLASMS; PARANEOPLASTIC SYNDROMES; TREATMENT OUTCOME;

EID: 33645886607     PISSN: 15289117     EISSN: 1540336X     Source Type: Journal    
DOI: 10.1097/00130404-200601000-00009     Document Type: Article

References (33)

1. Nelson KA, Walsh D, Abdullah O et al. Common complications of advanced cancer. Semin Oncol 2000;27:34-44.
2. Hurtado J, Esbrit P. Treatment of malignant hypercalcaemia. Expert Opin Pharmacother 2002;3:521-527.
3. Gucalp R, Ritch P, Wiernik PH et al. Comparative study of pamidronate disodium and etidronate disodium in the treatment of cancer-related hypercalcemia. J Clin Oncol 1992;10:134-142.
4. Gucalp R, Theriault R, Gill I et al. Treatment of cancer-associated hypercalcemia: double-blind comparison of rapid and slow intravenous infusion regimens of pamidronate disodium and saline alone. Arch Intern Med 1994;154:1935-1944.
5. Purohit OP, Radstone CR, Anthony C et al. A randomised double-blind comparison of intravenous pamidronate and clodronate in the hypercalcaemia of malignancy. Br J Cancer 1995;72:1289-1293.
6. Major P, Lortholary A, Hon J et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials. J Clin Oncol 2001;19:558-567.
7. Pecherstorfer M, Steinhauer EU, Rizzoli R et al. Efficacy and safety of ibandronate in the treatment of hypercalcemia of malignancy: a randomized multicentric comparison to pamidronate. Support Care Cancer 2003;11:539-547.
8. Warrell RP Jr, Israel R, Frisone M et al. Gallium nitrate for acute treatment of cancer-related hypercalcemia: a randomized, double-blind comparison to calcitonin. Ann Intern Med 1988;108:669-674.
9. Warrell RP Jr, Murphy WK, Schulman P et al. A randomized double-blind study of gallium nitrate compared with etidronate for acute control of cancer-related hypercalcemia. J Clin Oncol 1991;9:1467-1475.
10. Strewler GJ. The parathyroid hormone-related protein. N Engl J Med 2000;342:177-185.
11. Guise TA, Mundy GR. Cancer and bone. Endocr Rev 1998;19:18-54.
12. Walls J, Ratcliffe WA, Howell A et al. Response to intravenous bisphosphonate therapy in hypercalcemic patients with and without bone metastases: the role of parathyroid hormone-related protein. Br J Cancer 1994;70:169-172.
13. Gurney H, Grill V, Martin TJ. Parathyroid hormone-related protein and response to pamidronate in tumor-induced hypercalcaemia. Lancet 1993;341:1611-1613.
14. Wimalawansa SJ. Significance of plasma PTH-rp in patients with hypercalcemia of malignancy treated with bisphosphonate. Cancer 1994;73:2223-2230.
15. Chitambar CR. Apoptotic mechanisms of gallium nitrate: basic and clinical investigations. Oncology 2004;18(suppl):39-44.
16. Payne RB, Carver ME, Morgan DB. Interpretation of total serum calcium: effects of adjustment for albumin concentration on frequency of abnormal values and on detection of change in the individual. J Clin Pathol 1979;32:56-60.
17. Nussbaum SR, Younger J, Vandepol CJ et al. Single-dose intravenous therapy with pamidronate for the treatment of hypercalcemia of malignancy: comparison of 30-, 60-, and 90-mg dosages. Am J Med 1993;95:297-304.
18. Warrell RP Jr. Questions about clinical trials in hypercalcemia. J Clin Oncol 1988;6:759-761.
19. Warrell RP Jr. Metabolic emergencies. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: Principles and Practice of Oncology. 6th ed. Philadelphia: Lippincott Williams and Wilkins; 2001:2633-2645.
20. Bockman RS, Boskey AL, Blumenthal NC et al. Gallium increases bone calcium and crystallite perfection of hydroxyapatite. Calcif Tissue Int 1986;39:376-381.
21. Repo MA, Bockman RS, Betts F et al. Effect of gallium on bone mineral properties. Calcif Tissue Int 1988;43:300-306.
22. Bockman RS, Repo MA, Warrell RP Jr et al. Distribution of trace levels of therapeutic gallium in bone as mapped by synchrotron x-ray microscopy. Proc Natl Acad Sci U S A 1990;87:4149-4153.
23. Bockman RS. Studies on the mechanism of action of gallium nitrate. Semin Oncol 1991;18(suppl 5):21-25.
24. Warrell RP Jr, Bockman RS, Coonley CJ et al. Gallium nitrate inhibits calcium resorption from bone and is effective treatment for cancer-related hypercalcemia. J Clin Invest 1984;73: 1487-1490.
25. Hall TJ, Chambers TJ. Gallium inhibits bone resorption by a direct effect on osteoclasts. Bone Miner 1990;8:211-216.
26. Donnelly R, Bockman RS, Doty SB et al. Bone particles from gallium-treated rats are resistant to resorption in vivo. Bone Miner 1991;12:167-179.
27. Blair HC, Teitelbaum SL, Tan HL et al. Reversible inhibition of osteoclastic activity by bone-bound gallium (III). J Cell Biochem 1992;48:401-410.
28. Donnelly R, Boskey A. The effect of gallium on seeded hydroxyapatite growth. Calcif Tissue Int 1989;44:138-142.
29. Blumenthal NC, Cosma V, Levine S. Effect of gallium on the in vitro formation, growth, and solubility of hydroxyapatite. Calcif Tissue Int 1989;45:81-87.
30. Schlesinger PH, Teitelbaum SL, Blair HC. Osteoclast inhibition by Ga3+ contrasts with bisphosphonate metabolic suppression: competitive inhibition of H+ ATPase by bone-bound gallium. J Bone Miner Res 1991;6(suppl 1):S127.
31. Schlesinger PH, Blair HC. Mechanism of osteoclast inhibition by group IIIa metals; pH dependent release from the bone surface causes direct V-H+-ATPase inhibition without general metabolic inhibition. J Bone Miner Res 1999;14(suppl 1):S414.
32. Ruggiero SL, Mehrotra B, Rosenberg TJ et al. Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofac Surg 2004;62:527-534.
33. Bernstein LR. Mechanisms of therapeutic activity for gallium. Pharmacol Rev 1998;50:665-682.