Randomized, double-blinded phase II evaluation of docetaxel with or without doxercalciferol in patients with metastatic, androgen-independent prostate cancer

Clinical Cancer Research

Volumn 14, Issue 8, 2008, Pages 2437-2443

  Attia, Steven ^a   Eickhoff, Jens ^a   Wilding, George ^a   McNeel, Douglas ^a   Blank, Jules ^b   Ahuja, Harish ^c   Jumonville, Alcee ^d   Eastman, Michael ^e   Shevrin, Daniel ^f   Glode, Michael ^g   Alberti, Dona ^a   Staab, Mary Jane ^a   Horvath, Dottie ^a   Straus, Jane ^a   Marnocha, Rebecca ^a   Liu, Glenn ^a  

^a UNIVERSITY OF WISCONSIN   (United States)

^b Green Bay Oncology   (United States)

^c Aspirus Wausau Hospital   (United States)

^d GUNDERSEN LUTHERAN MEDICAL CENTER   (United States)

^e LC Ferguson Cancer Center   (United States)

^f EVANSTON NORTHWESTERN HEALTHCARE   (United States)

^g UNIVERSITY OF COLORADO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANDROGEN; DOCETAXEL; DOXERCALCIFEROL; PLACEBO; PROSTATE SPECIFIC ANTIGEN;

ABDOMINAL CRAMP; ADULT; ANEMIA; ARTICLE; CANCER SURVIVAL; CANCER THERAPY; CATARACT; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DYSPNEA; EDEMA; EMBOLISM; FATIGUE; FEBRILE NEUTROPENIA; FLUSHING; FOLLOW UP; HEMATURIA; HUMAN; HYPERCALCEMIA; HYPERGLYCEMIA; HYPERSENSITIVITY REACTION; HYPOPHOSPHATEMIA; INFECTION; INJECTION SITE REACTION; LACRIMATION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; NAIL; NAUSEA; NEUROPATHY; NEUTROPENIA; PLEURA EFFUSION; PRIORITY JOURNAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT RESPONSE;

AGED; AGED, 80 AND OVER; ANDROGENS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CALCIUM; DOUBLE-BLIND METHOD; ERGOCALCIFEROLS; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PROSTATIC NEOPLASMS; TAXOIDS;

EID: 42249098494     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-07-4274     Document Type: Article

References (39)

1. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin 2007;57:43-66.
2. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502-12.
3. Schwartz GG, Hulka BS. Is vitamin D deficiency a risk factor for prostate cancer? (Hypothesis). Anticancer Res 1990;10:1307-11.
4. Schwartz GG, Oeler TA, Uskokovic MR, Bahnson RR. Human prostate cancer cells: inhibition of proliferation by vitamin D analogs. Anticancer Res 1994;14:1077-81.
5. Skowronski RJ, Peehl DM, Feldman D. Actions of vitamin D3, analogs on human prostate cancer cell lines: comparison with 1,25-dihydroxyvitamin D3. Endocrinology 1995;136:20-6.
6. Hedlund TE, Moffatt KA, Uskokovic MR, Miller GJ. Three synthetic vitamin D analogues induce prostate-specific acid phosphatase and prostate-specific antigen while inhibiting the growth of human prostate cancer cells in a vitamin D receptor-dependent fashion. Clin Cancer Res 1997;3:1331-8.
7. Guzey M, Kitada S, Reed JC. Apoptosis induction by 1α,25- dihydroxyvitamin D3 in prostate cancer. Mol Cancer Ther 2002;1:667-77.
8. Schwartz GG, Wang MH, Zang M, Singh RK, Siegal GP. 1α,25- Dihydroxyvitamin D (calcitriol) inhibits the invasiveness of human prostate cancer cells. Cancer Epidemiol Biomarkers Prev 1997;6:727-32.
9. Getzenberg RH, Light BW, Lapco PE, et al. Vitamin D inhibition of prostate adenocarcinoma growth and metastasis in the Dunning rat prostate model system. Urology 1997;50:999-1006.
10. Lokeshwar BL, Schwartz GG, Selzer MG, et al. Inhibition of prostate cancermetastasis in vivo: a comparison of 1,23-dihydroxyvitamin D (calcitriol) and EB1089. Cancer Epidemiol Biomarkers Prev 1999;8:241-8.
11. Vegesna V, O'Kelly J, Said J, Uskokovic M, Binderup L, Koeffle HP. Ability of potent vitamin D3 analogs to inhibit growth of prostate cancer cells in vivo. Anticancer Res 2003;23:283-9.
12. Hedlund TE, Moffatt KA, Miller GJ. Stable expression of the nuclear vitamin D receptor in the human prostatic carcinoma cell line JCA-1: evidence that the antiproliferative effects of 1α,25-dihydroxyvitamin D3 are mediated exclusively through the genomic signaling pathway. Endocrinology 1996;137:1554-61.
13. Hedlund TE, Moffatt KA, Miller GJ. Vitamin D receptor expression is required for growth modulation by 1α,25-dihydroxyvitamin D3 in the human prostatic carcinoma cell line ALVA-31. J Steroid Biochem Mol Biol 1996;58:277-88.
14. Miller GJ, Stapleton GE, Ferrara JA, et al. The human prostatic carcinoma cell line LNCaP expresses biologically active, specific receptors for 1α,25-dihydroxyvitamin D3. Cancer Res 1992;52:515-20.
15. Miller GJ, Stapleton GE, Hedlund TE, Moffat KA. Vitamin D receptor expression, 24-hydroxylase activity, and inhibition of growth by 1α,25-dihydroxyvitamin D3 in seven human prostatic carcinoma cell lines. Clin Cancer Res 1995;1:997-1003.
16. Knutson JC, Hollis BW, LeVan LW, Valliere C, Gould KG, Bishop CW. Metabolism of 1α-hydroxyvitamin D2 to activated dihydroxyvitamin D2 metabolites decreases endogenous 1α,25-dihydroxyvitamin D3 in rats and monkeys. Endocrinology 1995;136:4749-53.
17. Strugnell S, Byford V, Makin HL, et al. 1α,24(S)-dihydroxyvitamin D2: a biologically active product of 1α-hydroxyvitamin D2 made in the human hepatoma, Hep3B. Biochem J 1995;310:233-41.
18. Upton RA, Knutson JC, Bishop CW, LeVan LW. Pharmacokinetics of doxercalciferol, a new vitamin D analogue that lowers parathyroid hormone. Nephrol Dial Transplant 2003;18:750-8.
19. Bailie GR, Johnson CA. Comparative review of the pharmacokinetics of vitamin D analogues. Semin Dial 2002;15:352-7.
20. Sjoden G, Smith C, Lindgren U, DeLuca HF. 1α-Hydroxyvitamin D2 is less toxic than 1α-hydroxyvitamin D3 in the rat. Proc Soc Exp Biol Med 1985;178:432-6.
21. Gallagher JC, Bishop CW, Knutson JC, Mazess RB, DeLuca HF. Effects of increasing doses of 1α-hydroxyvitamin D2 on calcium homeostasis in postmenopausal osteopenic women. J Bone Miner Res 1994;9:607-14.
22. Bauer JA, Thompson TA, Church DR, Ariazi EA, Wilding G. Growth inhibition and differentiation in human prostate carcinoma cells induced by the vitamin D analog 1α,24-dihydroxyvitamin D2. Prostate 2003;55:159-67.
23. Liu G, Oettel K, Ripple G, et al. Phase I trial of 1α- hydroxyvitamin D(2) in patients with hormone refractory prostate cancer. Clin Cancer Res 2002;8:2820-7.
24. Liu G, Wilding G, Staab MJ, et al. Phase II study of 1α- hydroxyvitamin D(2) in the treatment of advanced androgen-independent prostate cancer. Clin Cancer Res 2003;9:4077-83.
25. Hershberger PA, Yu WD, Modzelewski RA, et al. Calcitriol (1,25-dihydroxycholecalciferol) enhances paclitaxel antitumor activity in vitro and in vivo and accelerates paclitaxel-induced apoptosis. Clin Cancer Res 2001;7:1043-51.
26. Moffatt KA, Johannes WU, Miller GJ. 1α,25-Dihydroxyvitamin D3 and platinum drugs act synergistically to inhibit the growth of prostate cancer cell lines. Clin Cancer Res 1999;5:695-703.
27. Hershberger PA, McGuire TF, Yu WD, et al. Cisplatin potentiates 1,25-dihydroxyvitamin D3-induced apoptosis in association with increased mitogen-activated protein kinase kinase kinase 1 (MEKK-1) expression. Mol Cancer Ther 2002;1:821-9.
28. Ahmed S, Johnson CS, Rueger RM, Trump DL. Calcitriol (1,25- dihydroxycholecalciferol) potentiates activity of mitoxantrone/dexamethasone in an androgen independent prostate cancer model. J Urol 2002;168:756-61.
29. Ting HJ, Hsu J, Bao BY, Lee YF. Docetaxel-induced growth inhibition and apoptosis in androgen independent prostate cancer cells are enhanced by 1α,25-dihydroxyvitamin D3. Cancer Lett 2007;247:122-9.
30. Beer TM, Eilers KM, Garzotto M, Egorin MJ, Lowe BA, Henner WD. Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. J Clin Oncol 2003;21:123-8.
31. Beer TM, Ryan CW, Venner PM, et al. Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: a report from the ASCENT Investigators. J Clin Oncol 2007;25:669-74.
32. Tiffany NM, Ryan CW, Garzotto M, Wersinger EM, Beer TM. High dose pulse calcitriol, docetaxel and estramustine for androgen independent prostate cancer: a phase I/II study. J Urol 2005;174:888-92.
33. Bubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.
34. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.
35. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-14.
36. Henner WD, Beer TM. A new formulation of calcitriol (DN-101) for high-dose pulse administration in prostate cancer therapy. Rev Urol 2003;5 Suppl 3:S38-44.
37. Roessner M, de Wit R, Tannock IF. Prostate-specific antigen (PSA) response as a surrogate endpoint for overall survival (OS): analysis of the TAX 327 study comparing docetaxel plus prednisone with mitoxantrone plus prednisone in advanced prostate cancer on behalf of the TAX 327 investigators [abstract 4554]. J Clin Oncol 2004;23:395s.
38. Esquenet M, Swinnen JV, Heyns W, Verhoeven G. Control of LNCaP proliferation and differentiation: actions and interactions of androgens, 1α,25-dihydroxycholecalciferol, all-trans retinoic acid, 9-cis retinoic acid, and phenylacetate. Prostate 1996;28:182-94.
39. Feldman D, Skowronski RJ, Peehl DM. Vitamin D and prostate cancer. Adv Exp Med Biol 1995;375:53-63.