Pharmacokinetics and tolerability of a single dose of DN-101, a new formulation of catcitriol, in patients with cancer

Clinical Cancer Research

Volumn 11, Issue 21, 2005, Pages 7794-7799

  Beer, Tomasz M ^a   Javle, Milind ^b   Lam, Gilbert N ^c   Henner, W David ^d   Wong, Alvin ^d   Trump, Donald L ^b  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c MicroConstants Inc   (United States)

^d Novacea Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCITRIOL; CALCIUM; CHOLESTEROL; CREATININE; DN 101; GLUCOSE; SODIUM; UNCLASSIFIED DRUG;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DECREASED CREATININE CLEARANCE; DIARRHEA; DIZZINESS; DOSE CALCULATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG TOLERABILITY; EVALUATION; FATIGUE; FEMALE; HUMAN; HYPERCALCEMIA; HYPERCALCIURIA; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERPHOSPHATEMIA; HYPOALBUMINEMIA; HYPONATREMIA; KIDNEY DYSFUNCTION; MALE; NAUSEA; NOSE CONGESTION; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; SIDE EFFECT; SINGLE DRUG DOSE; SOLID TUMOR; THROMBOCYTOPENIA;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; AREA UNDER CURVE; BODY WEIGHT; CALCITRIOL; CALCIUM; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; PROSTATIC NEOPLASMS; TIME FACTORS;

EID: 27744528525     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-05-0552     Document Type: Article

References (36)

1. Feldman D, Skowronski RJ, Peehl DM. Vitamin D and prostate cancer. Adv Exp Med Biol 1995;375:53-63.
2. Guyton KZ, Kensler TW, Posner GH. Cancer chemoprevention using natural vitamin D and synthetic analogs. Annu Rev Pharmacol Toxicol 2001;41:421-42.
3. Beer TM, Myrthue A. Calcitriol in cancer treatment: from the lab to the clinic. Mol Cancer Ther 2004;3:373-81.
4. Bernard: RJ, Trump DL, Yu WD, McGuire TF, Hershberger PA, Johnson CS. Combination of 1α,25-dihydroxyvitamin D(3) with dexamethasone enhances cell cycle arrest and apoptosis: role of nuclear receptor cross-talk and Erk/Akt signaling. Clin Cancer Res 2001;7:4164-73.
5. Yu WD, McElwain MC, Modzelewski RA, et al. Enhancement of 1,25-dihydroxyvitamin D3-mediated antitumor activity with dexamethasone. J Natl Cancer Inst 1998;90:134-41.
6. Guzey M, Sattler C, DeLuca HF. Combinational effects of vitamin D3 and retinoic acid (all trans and 9 cis) on proliferation, differentiation, and programmed cell death in two small cell lung carcinoma cell lines. Biochem Biophys Res Commun 1998;249:735-44.
7. Koga M, Sutherland RL. Retinoic acid acts synergistically with 1,25-dihydroxyvitamin D3 or antioestrogen to inhibitT-47D human breast cancer cell proliferation. J Steroid Biochem Mol Biol 1991;39:455-60.
8. Anzano MA, Smith JM, Uskokovic MR, et al. 1α25-Dihydroxy-16-ene-23- yne-26,27-hexafluorocholecalciferol (Ro24-5531), a new deltanoid (vitamin D analogue) for prevention of breast cancer in the rat. Cancer Res 1994;54:1653-6.
9. Welsh J. Induction of apoptosis in breast cancer cells in response to vitamin D and antiestrogens. Biochem Cell Biol 1994;72:537-45.
10. Abe-Hashimoto J, Kikuchi T, Matsumoto T, Nishii Y, Ogata E, Ikeda K. Antitumor effect of 22-oxa-calcitriol, a noncalcemic analogue of calcitriol, in athymic mice implanted with human breast carcinoma and its synergism with tamoxifen. Cancer Res 1993;53:2534-7.
11. Dunlap N, Schwartz GG, Eads D, et al. 1α,25-Dihydroxyvitamin D(3) (calcitriol) and its analogue, 19-nor-1α,25(OH)(2)D(2), potentiate the effects of ionising radiation on human prostate cancer cells. Br J Cancer 2003;89:746-53.
12. Polar MK, Gennings C, Park M, Gupta MS, Gewirtz DA. Effect of the vitamin D3 analog ILX 23-7553 on apoptosis and sensitivity to fractionated radiation in breast tumor cells and normal human fibroblasts. Cancer Chemother Pharmacol 2003;51:415-21.
13. Beer TM, Hough KM, Garzotto M, Lowe BA, Henner WD. Weekly high-dose calcitriol and docetaxel in advanced prostate cancer. Semin Oncol 2001;28:49-55.
14. Hershberger PA, Yu WD, Modzelewski RA, Rueger RM, Johnson CS, Trump DL. 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.
15. Moftatt 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.
16. Light BW, Yu WD, McElwain MC, Russell DM, Trump DL, Johnson CS. Potentiation of cisplatin antitumor activity using a vitamin D analogue in a murine squamous cell carcinoma model system. Cancer Res 1997;57:3759-64.
17. 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.
18. Sundaram S, Chaudhry M, Reardon D, Gupta M, Gewirtz DA. The vitamin D3 analog EB 1089 enhances the antiproliferative and apoptotic effects of Adriamycin in MCF-7 breast tumor cells. Breast Cancer Res Treat 2000;63:1-10.
19. Torres R, Calle C, Aller P, Mata F. Etoposide stimulates 1,25-dihydroxyvitamin D3 differentiation activity, hormone binding and hormone receptor expression in HL-60 human promyelocytic cells. Mol Cell Biochem 2000;208:157-62.
20. McElwain MC, Dettelbach MA, Modzelewski RA, et al. Antiproliferative effects in vitro and in vivo of 1,25-dihydroxyvitamin D3 analog in a squamous cell carcinoma model system. Mol Cel Differ 1995;3:31-50.
21. 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.
22. Modzelewski RA, Hershberger PA, Johnson CS, Trump DL. Apoptotic effects of paclitaxel and calcitriol in rat dunning MLL and human PC-3 prostate tumors in vitro. Proc AACR 1999;40:580.
23. Kumagai T, O'Kelly J, Said JW, Koeffler HP. Vitamin D2 analog 19-nor-1,25-dihydroxyvitamin D2: antitumor activity against leukemia, myeloma, and colon cancer cells. J Natl Cancer Inst 2003;95:896-905.
24. Osborn JL, Schwartz GG, Smith DC, Bahnson RR, Day R, Trump DL. Phase II trial of oral 1,25-dihydroxyvitamin D (calcitriol) in hormone refractory prostate cancer. Urol Oncol 1995;1:195-8.
25. Gross C, Stamey T, Hancock S, Feldman D. Treatment of early recurrent prostate cancer with 1,25-dihydroxyvitamin D3 (calcitriol). J Urol 1998;159:2035-9.
26. Koeffler HP, Hirji K, Itri L. 1,25-Dihydroxyvitamin D3: in vivo and in vitro effects on human preleukemic and leukemic cells. Cancer Treat Rep 1985;69:1399-407.
27. Rustin GJ, Quinnell TG, Johnson J, Clarke H, Nelstrop AE, Bollag W. Trial of isotretinoin and calcitriol monitored by CA 125 in patients with ovarian cancer. Br J Cancer 1996;74:1479-81.
28. Smith DC, Johnson CS, Freeman CC, Muindi J, Wilson JW, Trump DL. A Phase I trial of calcitriol (1,25-dihydroxycholecalciferol) in patients with advanced malignancy. Clin Cancer Res 1999;5:1339-45.
29. Beer TM, Munar M, Henner WD. A Phase I trial of pulse calcitriol in patients with refractory malignancies: pulse dosing permits substantial dose escalation. Cancer 2001;91:2431-9.
30. Beer TM, Lemmon D, Lowe BA, Henner WD. High-dose weekly oral calcitriol in patients with a rising PSA after prostatectomy or radiation for prostate carcinoma. Cancer 2003;97:1217-24.
31. Muindi JR, Peng Y, Potter DM, et al. Pharmacokinetics of high-dose oral calcitriol: results from a phase 1 trial of calcitriol and paclitaxel. Clin Pharmacol Ther 2002;72:648-59.
32. Lam FC, Hung CT, Perrier DG. Estimation of variance for harmonic mean half-lives. J Pharm Sci 1985;74:229-31.
33. Muindi JR, Peng Y, Potter DM, Johnson CS, Trump DL. Pharmacokinetics of liquid calcitriol formulation in advanced solid tumor patients: comparison with caplet formulation. Cancer Chem Pharm. In press.
34. Garzotto M, Beer TM. Syndrome of inappropriate antidiuretic hormone secretion: a rare complication of prostate cancer. J Urol 2001;166:1386.
35. Muindi JR, Modzelewski RA, Peng Y, Trump DL, Johnson CS. Pharmacokinetics of 1α,25-dihydroxyvitamin D3 in normal mice after systemic exposure to effective and safe antitumor doses. Oncology 2004;66:62-6.
36. Trump DL, Hershberger PA, Bernardi RJ, et al. Antitumor activity of calcitriol: pre-clinical and clinical studies. J Steroid Biochem Mol Biol 2004;89-90:519-26.