A phase II trial of all-trans-retinoic acid in hormone-refractory prostate cancer: A clinical trial with detailed pharmacokinetic analysis

Cancer Chemotherapy and Pharmacology

Volumn 39, Issue 4, 1997, Pages 349-356

  Trump, Donald L ^a,b   Smith, David C ^a,b   Stiff, Dwight ^a,c   Adedoyin, Adedayo ^a,c   Day, Roger ^a,d   Bahnson, Robert R ^a,b   Hofacker, Janie ^a   Branch, Robert A ^a,b,c  

^a UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^d UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

All trans retinoic acid; Pharmacokinetics; Prostate cancer; Total body clearance

Indexed keywords

RETINOIC ACID; RETINOID;

ADULT; ANTINEOPLASTIC ACTIVITY; ARTICLE; BALANITIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONJUNCTIVITIS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG TISSUE LEVEL; HEADACHE; HUMAN; MALE; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; SIDE EFFECT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; HUMANS; LEUKOCYTES; MALE; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; TRETINOIN; TUMOR MARKERS, BIOLOGICAL; VITAMIN A;

EID: 0031014516     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002800050582     Document Type: Article

References (39)

1. Crawford ED, Eisenberger MA, McLeod DG, Spaulding JT, Benson R, Door FA, Blumenstein BA, Davis MA, Goodman PJ (1989) A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med 321:419
2. Iversen P, Rasmussen F, Klarskov P, Christensen IJ (1993) Long-term results of Danish Prostatic Cancer Group trial 86: goserelin acetate plus flutamide versus orchiectomy in advanced prostate cancer. Cancer 72: 3851
3. Seidman AD, Scher HI, Petrylak D, Dershaw DD, Curley T (1992) Estramustine and vinblastine: use of PSA as a clinical endpoint for hormone refractory prostate cancer. J Urol 147:931
4. Eisenberger MA, Reyno LM, Jodrell DI, Sinibaldi VJ, Tkaczuk, KH, Sridhara R, Zuhowski EG. Lowitt MH, Jacobs SC, Egorin MJ (1993) Suramin, an active drug for prostate cancer: interim observations in a phase 1 trial. J Natl Cancer Inst 85:611
5. Pienta KJ, Redman B, Hussain M, Cummings G, Esper PS, Appel C, Flaherty LE (1994) Phase II evaluation of oral estramustine and oral etoposide in hormone-refractory adenocarcinoma of the prostate. J Clin Oncol 12:2005
6. Reichman ME, Hayes RB, Ziegler RG, Schatzkin A, Taylor PR, Kahle LL, Fraumeni JF Jr (1990) Serum vitamin A and subsequent development of prostate cancer in the first national health and nutrition examination survey epidemiologic follow-up study. Cancer Res 50:2311
7. Ohno Y, Yoshida O, Oishi K, Okada K, Yamabe H, Schroeder FH (1988) Dietary β-carotene and cancer of the prostate: a casecontrol study in Kyoto, Japan. Cancer Res 48:1331
8. Whelan P, Walker BE, Kelleher J (1983) Zinc, vitamin A, and prostatic cancer. Br J Urol 55:525
9. Chaproniere DM, Webber MM (1985) Dexamethasone and retinyl acetate similarly inhibit and stimulate EGF- or insulin-induced proliferation of prostatic epithelium. J Cell Physiol 122:249
10. Meyskens F, Alberts D, Salmon S (1983) Effect of 13-cisretinoic acid and 4-hydroxyphenyl-all-trans-retinamide on human tumor colony formation in soft agar. Int J Cancer 32:295
11. Cowan J, von Hoff D, Dinesman A, Clark G (1983) Use of a human tumor cloning system to screen retinoids for antineoplastic activity. Cancer 51:92
12. Pollard M, Lucker PH, Sporn MB (1991) Prevention of primary prostate cancer in Lobund-Wistar rats by N-(4-hydroxyphenyl) retinamide. Cancer Res 51:3615
13. Slawin K, Kadmon D, Park SH, Scardino PT, Anzano M, Sporn MB, Thompson TC (1993) Dietary fenretinide, a synthetic retinoid, decreases the tumor incidence and the tumor mass of ras + myc-induced carcinomas in the mouse prostate reconstitution model system. Cancer Res 53:4461
14. Trump DL (1994) Retinoids in bladder, testis and prostate cancer: epidemiologic, preclinical and clinical observations. Leukemia 8 [Suppl 3]:S50
15. Muindi JRF, Frankel SR, Huselton C, DeGrazia F, Garland WA, Young CW Warrell RPJr (1992) Clinical pharmacology of oral all-trans retinoic acid in patients with acute promyelocytic leukemia. Cancer Res 52:2138
16. Smith MA, Adamson PC, Balis FM, Fuesner J, Aronson L, Murphy RF, Horowitz ME, Reaman G, Hammond GD, Fenton RM, Connaghan GD, Hittlelman WN, Poplack DG. (1992) Phase I and pharmacokinetic evaluation of all-transretinoic acid in pediatric patients with cancer. J Clin Oncol 10:1666
17. Muindi J, Frankel SR, Miller WH Jr, Jakubowski A, Scheinberg DA, Young C, Dmitrovsky E, Warrell RP Jr (1992) Continuous treatment with all-trans retinoic acid causes progressive reduction in plasma drug concentration: implications for relapse and retinoid "resistance" in patient with acute promyelocytic leukemia. Blood 79:299
18. Rigas JR, Francis PA, Muindi JRF, Kris MG, Huselton C, DeGrazia F, Orazem JP, Young CW, Warrell RP Jr (1993) Constitutive variability in the pharmacokinetics of the natural retinoid. all-rrans-retinoic acid, and its modulation by ketoconazole. J Natl Cancer Inst 85: 1921
19. Miller VA, Rigas JR, Muindi JRF, Tong WP. Venkatraman E, Kris MG, Warrell RP (1994) Modulation of all-trans retinoic acid pharmacokinetics by liarozole. Cancer Chemother Pharmacol 34:522
20. Leo MA, Lasker JM, Raucy JL, Kim CL, Black M, Lieber CS (1989) Metabolism of retinol and retinoic acid by human liver cytochrome P450IIC8. Arch Biochem Biophys 269:305
21. Wauwe J van, Coene M-C, Goossens J, Van Nigen G, Cools W, Lauwers W (1988) Ketoconazole inhibits the in vitro and in vivo metabolism of all-trans-retinoic acid. J Pharmacol Exp Ther 245:718
22. Wauwe J van, Coene M-C, Goossens J, Cools W, Monbaliu J (1990) Effects of cytochrome P-450 inhibitors on the in vivo metabolism of all-trans-retinoic acid in rats. J Pharmacol Exp Ther 252:365
23. Martini R, Murray M (1993) Participation of P450 3A enzymes in rat hepatic microsomal retinoic acid 4-hydroxylation. Arch Biochem Biophys 303:57
24. Oken MM, Creech RH, Tormey DC, et al (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649
25. Bugge CJL, Rodriquez LC, Vane FM (1985) Determination of isotretinoin or etretinate and their major metabolites in human blood by reversed-phase high-performance liquid chromatography. J Pharm Biomed Anal 3: 269
26. Lasnitzki I (1976) Reversal of methylcholanthrene-induced changes in mouse prostates in vitro by retinoic acid and its analogues. Br J Cancer 34:239
27. Moon RC, Grubbs CJ, Sporn MB (1976): Inhibition of 7,12-dimethylbenz(a)antracene-induced mammary carcinogenesis by retinyl acetate. Cancer Res 36:2626
28. Bollag W (1972) Prophylaxis of chemically induced benign and malignant epithelial tumors by vitamin A acid (retinoic acid). Eur J Cancer 8:689
29. Meyskens FL Jr, Surwit E, Moon TE, Childers JM, Davis JR, Door RT, Johnson CS, Alberts DS (1994) Enhancement of regression of cervical intraepithelia neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial. J Natl Cancer Inst 86:539
30. Hong WK, Lippman, Itri LM, Karp DD, Lee JS, Byers RM, Schantz SP, Kramer AM, Lotan R, Peters LJ, Dimery IW, Brown BW, Goepfert H (1990) Prevention of second primary tumors with isotretinoin in squamous cell carcinoma of the head and neck. N Engl J Med 323:795
31. Lippman SM, Glisson BS, Kavanaugh JJ, Lotan R, Hong WK, Paredes-Espinoza M, Hittelman WN, Holdener EE, Krakoff IH (1992) Retinoic acid and interferon combination studies in human cancer. Eur J Cancer 29a [Suppl 5] : S0
32. Huang ME, Ye YI, Chen SR, Chai JR, Lu JX, Zhoa L, Gu LJ and Wang ZY (1988) Use of all-trans-retinoic acid in the treatment of acute promyelocytic leukemia. Blood 72:567
33. Warrel RP Jr, Frankel SR, Miller WH, Scheinberg DA, Itri LM, Hittelman WN, Vyas R, Andreff A, Tafudi A, Jakubowski A, Gabrilove J, Gordon M, Dmitrovsky E (1991) Differentiation therapy of acute promyelocytic leukemia with tretinoin (all-trans retinoic acid). N Engl J Med 324: 1385
34. Pienta KJ, Nguyet NM, Lehr JE (1993) Treatment of prostate cancer in the rat with the synthetic retinoid fenretinide. Cancer Res 53:224
35. Kelly WK, Scher HI, Muindi J, Bajorin D, O'Moore P, Reuter V, Young CW, Curley T, Liebertz C (1993) Phase II of all-trans retinoic acid in patients with adenocarcinoma. Proc Annu Meet Am Soc Clin Oncol 34:1210
36. Adamson PC, Bailey J, Pluda J, Poplack DG, Bauza S, Murphy RF, Yarchoan R, Balis FM (1995) Pharmacokinetics of all-trans-retinoic acid administered on an intermittent schedule. J Clin Oncol 13:1238
37. Lee JS, Newman RA, Lippman SM, Fossella FV, Calayag M, Raber MN, Krakoff IH, Hong WK (1995) Phase I evaluation of all-trans retinoic acid with and without ketoconazole in adults with solid tumors. J Clin Oncol 13:1501
38. Muindi JF, Scher HI, Rigas JR, Warrell RP, Young CW (1995) Elevated plasma lipid peroxide content correlates with rapid plasma clearance of all-trans retinoic acid in patients with advanced cancer. Cancer Res 54:2125
39. Adamson PC, Boylan JF, Balis FM, Murphy RF, Godwin KA, Gudas LJ, Poplack DG (1993) Time course of induction of metabolism of all-trrans-retinoic acid and the up regulation of cellular retinoic acid-binding protein. Cancer Res 53:472