Phase II study of suramin plus aminoglutethimide in two cohorts of patients with androgen-independent prostate cancer: Simultaneous antiandrogen withdrawal and prior antiandrogen withdrawal

Clinical Cancer Research

Volumn 4, Issue 1, 1998, Pages 37-44

  Dawson, Nancy ^a,b   Figg, William D ^a   Brawley, Otis W ^a   Bergan, Raymond ^a   Cooper, Michael R ^a,c   Senderowicz, Adrian ^a   Headlee, Donna ^a   Steinberg, Seth M ^a   Sutherland, Melissa ^a   Patronas, Nicholas ^a   Sausville, Edward ^a   Linehan, W Marston ^a   Reed, Eddie ^a   Sartor, Oliver ^a,d  

^a NATIONAL CANCER INSTITUTE   (United States)

^b WALTER REED ARMY MEDICAL CENTER   (United States)

^c UNIVERSITY OF VERMONT   (United States)

^d LOUISIANA STATE UNIV MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOGLUTETHIMIDE; ANTIANDROGEN; FLUTAMIDE; HYDROCORTISONE; LEUPRORELIN; SURAMIN;

ADRENAL SUPPRESSION; ADULT; AGED; APPETITE DISORDER; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DRUG INDUCED DISEASE; DRUG RESPONSE; DRUG WITHDRAWAL; FATIGUE; FEVER; GASTROINTESTINAL SYMPTOM; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; RASH;

ADULT; AGED; AGED, 80 AND OVER; AMINOGLUTETHIMIDE; ANDROGEN ANTAGONISTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; HUMANS; MALE; MIDDLE AGED; PROSTATIC NEOPLASMS; SURAMIN; SURVIVAL RATE;

EID: 17744374787     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (65)

1. Wingo, P. A., Tong, T., and Bolden, S. Cancer statistics. CA Cancer J. Clin., 45: 8-30, 1995.
2. Crawford, E. D., Eisenberger, M. A., McCleod, D. G., Spaulding, J. T., Benson, R., Dorr, F. A., and Blumenstein, B. A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N. Engl. J. Med., 321: 419-424, 1989.
3. Prostate Cancer Trialists' Collaborative Group. Maximum androgen blockade in advanced prostate cancer: an overview of 22 randomized trial with 3283 deaths in 5710 patients. Lancet, 346: 265-269, 1995.
4. Middleman, M. N., Lush, R. M., Sartor, O., Reed, E., and Figg, W. D. Treatment approaches for metastatic cancer of the prostate based on recent molecular evidence. Cancer Treat. Rev., 22: 105-118, 1996.
5. Figg, W. D., Middleman, M. N., and Sartor, O. Therapeutic options in patients with hormone-refractory prostate cancer. Am. J. Med., 100: 243-244, 1996.
6. Scher, H. I., and Kelly, W. K. Flutamide withdrawal syndrome: its impact on clinical trials in hormone-refractory prostate cancer. J. Clin. Oncol., 11: 1566-1572, 1993.
7. Figg, W. D., Sartor, O., Cooper, M. R., Thibault, A., Bergan, R. C., Dawson, N., Reed, E., and Myers, C. E. Prostate specific antigen decline following the discontinuation of flutamide in patients with stage D2 prostate cancer. Am. J. Med., 98: 412-414, 1995.
8. Small, E. J., and Srinivas, S. The antiandrogen withdrawal syndrome: experience in a large cohort of unselected patients with advanced prostate cancer. Cancer (Phila.), 76: 1428-1434, 1995.
9. Herrada, J., Dieringer, P., and Logothetis, C. J. Characterization of patients with androgen-independent prostatic carcinoma whose serum prostate specific antigen decreased following flutamide withdrawal. J. Urol., 155: 620-623, 1996.
10. Middleman, M. N., Lush, R. M., and Figg, W. D. The mutated androgen receptor and its implications for the treatment of metastatic carcinoma of the prostate. Pharmacotherapy, 16: 376-381, 1996.
11. Hawking, F. Suramin: with special reference to onchocerciasis. Adv. Pharmacol. Chemother., 15: 289-322, 1978.
12. Broder, S., Yarchoan, R., Collins, J. M., Lane, H. C., Markham, P. D., Klecker, R. W., Redfield, R. R., Mitsuya, H., Hoth, D. F., Gelmann, E., Resnick, L., Myers, C. E., and Fauci, A. S. Effects of suramin on HTLV III/LAV infection presenting as Kaposi's sarcoma or AIDS-related complex: clinical pharmacology and suppression of virus replication in vivo. Lancet, 2: 627-630, 1985.
13. Myers, C., Cooper, M., Stein, C., LaRocca, R., Walther, M. M., Weiss, G., Choyke, P., Dawson, N., Steinberg, S., Uhrich, M. M., Cassidy, J., Kohler, D. R., Trepel, J., and Linehan, W. M. Suramin. A novel growth factor antagonist with activity in hormone-refractory metastatic prostate cancer. J. Clin. Oncol., 10: 881-889, 1992.
14. Scher, H. I. Suramin. Here to stay!? J. Natl. Cancer Inst., 85: 594-597, 1993.
15. Eisenberger, M. A., Reyno, L. M., Jodrell, D. I., Sinibaldi, V. J., Tkaczuk, K. H., Sridhara, R., Zuhowski, E. G., Lowitt, M. H., Jacobs, S. C., and Egorin, M. J. Suramin, an active drug for prostate cancer: interim observations in a Phase I trial. J. Natl. Cancer Inst., 85: 611-621, 1993.
16. Reyno, L. M., Egorin, M. J., Eisenberger, M. A., Sinibaldi, V. J., Zuhowski, E. G., and Sridhara, R. Development and validation of a pharmacokinetically based fixed dosing scheme for suramin. J. Clin. Oncol., 13: 2187-2195, 1995.
17. Kelly, W. K., Curley, T., Leibertz, C., Dnistrian, A., Schwartz, M., and Scher, H. I. Prospective evaluation of hydrocortisone and suramin in patients with androgen-independent prostate cancer. J. Clin. Oncol., 13: 2208-2213, 1995.
18. Kobayashi, K., Vokes, E. E., Vogelzang, N. J., Janisch, L., Soliven, B., and Ratain, M. J. Phase I study of suramin given by intermittent infusion without adaptive control in patients with advanced cancer. J. Clin. Oncol., 13: 2196-2207, 1995.
19. Eisenberger, M. A., Sinibaldi, V. J., Renyo, L. M., Sridhara, R., Jodrell, D. I., Zuhowski, E. G., Tkaczuk, K. H., Lowitt, M. H., Hemady, R. K., Jacobs, S. C., VanEcho, D., and Egorin, M. J. Phase I and clinical evaluation of a pharmacologically guided regimen of suramin in patients with hormone-refractory prostate cancer. J. Clin. Oncol., 13: 2174-2186, 1995.
20. Bowden, C. J., Figg, W. D., Dawson, N. A., Sartor, O., Bitton, R. J., Weinberger, M. S., Headlee, D. J., Reed, E., Myers, C. E., and Cooper, M. R. A Phase I/II study of continuous infusion suramin in patients with hormone-refractory prostate cancer: toxicity and response. Cancer Chemother. Pharmacol., 39: 1-8, 1996.
21. Dawson, N. A., Cooper, M. R., Figg, W. D., Headlee, D. J., Thibault, A., Bergan, R. C., Steinberg, S. M., Sausville, E. A., Myers, C. E., and Sartor, O. Antitumor activity of suramin in hormone-refractory prostate cancer controlling for hydrocortisone treatment and flutamide withdrawal as potentially confounding variables. Cancer (Phila.), 76: 453-462, 1995.
22. Kelly, W. K., Scher, H. I., Mazumdar, M., Pfister, D., Curley, T., Leibertz, C., Cohen, L., Vlamis, V., Dnistrian, A., and Schwartz, M. Suramin and hydrocortisone: determining drug efficacy in androgen-independent prostate cancer. J. Clin. Oncol., 13: 2214-2222, 1995.
23. Stein, C. A., LaRocca, R. V., Thomas, R., McAtee, N., and Myers, C. E. Suramin. An anticancer drug with a unique mechanism of action. J. Clin. Oncol., 7: 499-508, 1989.
24. Thibault, A., Figg, W. D., Cooper, M. R., Prindiville, S. A., Sartor, A. O., Headlee, D. J., and Myers, C. E. Anaphylactoid reaction with suramin. Pharmacotherapy, 13: 656-657, 1993.
25. Dawson, N. A., Lush, R. M., Steinberg, S. M., Tompkins, A. C., Headlee, D. J., and Figg, W. D. Suramin-induced neutropenia. Eur. J. Cancer, 32A: 1534-1539, 1996.
26. Figg, W. D., Cooper, M. R., Thibault, A., Headlee, D. J., Humphrey, J., Bergan, R. C., Reed, E., and Sartor, O. Acute renal toxicity associated with suramin in the treatment of prostate cancer. Cancer (Phila.), 74: 1612-1614, 1994.
27. Tisdale, J. F., Figg, W. D., Reed, E., McCall, N. A., Alkins, B. R., and Home, M. K. Severe thrombocytopenia in patients treated with suramin: evidence for an immune mechanism in one. Am. J. Hematol., 57: 152-157, 1996.
28. Home, M. K., Wilson, O. J., Cooper, M., Gralnick, H. R., and Myers, C. E. The effect of suramin on laboratory tests of coagulation. Thromb. Haemost., 67: 434-439, 1992.
29. O'Donnell, B. P., Dawson, N. A., Weiss, R. B., Myers, C. E., and James, W. D. Suramin-induced skin reactions. Arch. Dermatol., 128: 75-79, 1992.
30. LaRocca, R. V., Cooper, M. R., Uhrich, M., Danesi, R., Walther, M. M., Linehan, W. M., and Myers, C. E. Use of suramin in treatment of prostatic carcinoma refractory to conventional hormonal manipulation. Urol. Clin. N. Am., 18: 123-129, 1991.
31. LaRocca, R. V., Meer, J., Gilliatt, R. W., Stein, C. A., Cassidy, J., Myers, C. E., and Dalakas, M. C. Suramin-induced polyneuropathy. Neurology, 40: 954-960, 1990.
32. Bitton, R. J., Figg, W. D., Venzon, D. J., Dalakas, M. C., Bowden, C., Headlee, D. J., Reed, E., Myers, C. E., and Cooper, M. R. Pharmacologic variables associated with the development of neurologic toxicity in patients treated with suramin. J. Clin. Oncol., 13: 2223-2229, 1995.
33. Small, E. J., Egan, B., Apodoca, D., and Fippin, L. Ketoconazole retains significant activity in patients with advanced prostate cancer who have progressed despite flutamide withdrawal. Proc. Am. Soc. Clin. Oncol., 15: 657, 1996.
34. Drago, J. R., Santen, R. J., Lipton, A., Worgul, T. J., Harvey, H. A., Boucher, A., Manni, A., and Rohner, T. J. Clinical effect of aminoglutethimide, medical adrenalectomy, in treatment of 43 patients with advanced prostatic carcinoma. Cancer (Phila.), 53: 1447-1450, 1984.
35. Santen, R. J., and Misbin, R. I. Aminoglutethimide: review of pharmacology and clinical use. Pharmacotherapy, 1: 95-120, 1981.
36. Figg, W. D., Thibault, A., Sartor, A. O., Mays, D., Headlee, D. J., Calls, K. A., and Cooper, M. R. Hypothyroidism associated with aminoglutethimide in patients with prostate cancer. Arch. Intern. Med., 154: 1023-1025, 1994.
37. Santen, R. J., and Wells, S. A. The use of aminoglutethimide in the treatment of patients with metastatic carcinoma of the breast. Cancer (Phila.), 46: 1066-1074, 1980.
38. Sartor, O., Cooper, M., Weinberger, M., Headlee, D. J., Thibault, A., Tompkins, A., Steinberg, S., Figg, W. D., Linehan, W. M., and Myers, C. E. Surprising activity of flutamide withdrawal, when combined with aminoglutethimide, in treatment of "hormone-refractory" prostate cancer. J. Natl. Cancer Inst., 86: 222-227, 1994.
39. Kelly, W., Scher, H., Mazumdar, M., Vlamis, V., Schwartz, M., and Fossa, S. Prostate-specific antigen as a measure of disease outcome in metastatic hormone-refractory prostate cancer. J. Clin. Oncol., 11: 607-615, 1993.
40. Sridhara, R., Eisenberger, M., Sinibaldi, V., Reyno, L., and Egorin, M. Evaluation of prostate-specific antigen as a surrogate marker for response of hormone-refractory prostate cancer to suramin therapy. J. Clin. Oncol., 13: 2944-2953, 1995.
41. Wittes, R. E. (ed.), Appendix A. Grading of Toxicity. In: Manual of Oncologic Therapeutics, pp. 445-448. Philadelphia: J. B. Lippincott Co., 1992.
42. Supko, J. G., and Malspeis, L. A rapid isocratic HPLC assay of suramin (NSC 34936) in human plasma. J. Liquid Chromatogr., 13: 727-741, 1990.
43. Cooper, M. R., Lieberman, R., LaRocca, R. V., Gernt, P. R., Weinberger, M. S., Headlee, D. J., Kohler, D. R., Goldspiel, B. R., Peck, C. C., and Myers, C. E. Adaptive control with feedback strategies for suramin dosing. Clin. Pharmacol. Ther., 52: 11-23, 1992.
44. Figg, W. D., Stevens, J. A., and Cooper, M. R. Adaptive control with feedback of suramin using intermittent infusions. J. Clin. Oncol., 12: 1523-1524, 1994.
45. Crawford, E. D. Challenges in the management of prostate cancer. Br. J. Urol., 70: 33-38, 1992.
46. Moore, M. J., Osoba, D., Murphy, K., Tannock, I. F., Armitage, A., Findlay, B., Coppin, C., Neville, A., Venner, P., and Wilson, J. Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer. J. Clin. Oncol., 12: 689-694, 1994.
47. Marshall, M. E., Blumenstein, B., Crawford, E. D., Thompson, I. M., Craig, J. B., Eisenberger, M., and Ahmann, F. Phase II trial of amonafide for the treatment of advanced, hormonally refractory carcinoma of the prostate. A southwest oncology group study. Am J. Clin. Oncol., 17: 514-515, 1994.
48. Hussain, M. H., Pienta, K. J., Redman, B. G., Cummings, G. D., and Flaherty, L. E. Oral etoposide in the treatment of hormone-refractory prostate cancer. Cancer (Phila.), 74: 100-103, 1994.
49. Tannock, I. F., Osoba, D., Stockier, M. R., Ernst, D. S., Neville, A. J., Moore, M. J., Armitage, G. R., Wilson, J. J., Venner, P. M., Coppin, C. M., and Murphy, K. C. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J. Clin. Oncol., 14: 1756-1764, 1996.
50. Pienta, K. J., Reddman, B., Hussain, M., Cummings, G., Esper, P. S., Appel, C., and Flaherty, L. E. Phase II evaluation of oral estramustine and oral etoposide in hormone-refractory adenocarcinoma of the prostate. J. Clin. Oncol., 12: 2005-2012, 1994.
51. Hudes, G. R., Greenberg, R., Krigel, R. L., Fox, S., Scher, R., Litwin, S., Watts, P., Speicher, L., Tew, K., and Comis, R. Phase II study of estramustine and vinblastine, two microtubule inhibitors, in hormone-refractory prostate cancer. J. Clin. Oncol., 10: 1754-1761, 1992.
52. Raghavan, D., Cox, K., Pearson, B. S., Coorey, G. J., Rogers, J., Watt, W. H., Coates, A. S., McNeil, E., and Grygiel, J. J. Oral cyclophosphamide for the management of hormone refractory prostate cancer. Br. J. Urol., 72: 625-628, 1993.
53. Sella, A., Kilbourn, R., Amato, R., Bui, C., Zukiwski, A. A., Ellerhorst, J., and Logothetis, C. J. Phase II study of ketoconazole combined with weekly doxorubicin in patients with androgen-independent prostate cancer. J. Clin. Oncol., 12: 683-688, 1994.
54. Figg, W. D., Dawson, N., Middleman, M. N., Brawley, O., Lush, R. M., Senderowicz, A., Steinberg, S. M., Tompkins, A., Reed, E., and Sartor, O. Flutamide withdrawal and concomitant initiation of aminoglutethimide in patients with "hormone refractory" prostate cancer. Acta Oncol., 35: 405-408, 1996.
55. Middleman, M. N., Lush, R. M., Sartor, O., Reed, E., and Figg, W. D. Prolonged response to flutamide withdrawal and initiation of aminoglutethimide in a patient with metastatic prostate cancer. J. Oncol. Pharm. Practice, 1: 45-47, 1995.
56. Dupont, A., Gomez, J. L., Cusan, L., Koutsilieris, M., and Labrie, F. Response to flutamide withdrawal in advanced prostate cancer in progression under combination therapy. J. Urol., 150: 908-913, 1993.
57. Culig, Z., Hobisch, A., Cronauer, M. V., Cato, A. C., Hittmair, A., Radmayr, C., Eberle, J., Bartsch, G., and Klocker, H. Mutant androgen receptor detected in an advanced-stage prostatic carcinoma is activated by adrenal androgens and progesterone. Mol. Endocrinol., 7: 1541-1550, 1993.
58. Suzuki, H., Sato, N., Watabe, Y., Masai, M., Seino, S., and Shimazaki, J. Androgen receptor gene mutations in human prostate cancer. J. Steroid Biochem. Mol. Biol., 46: 759-765, 1993.
59. Gaddipati, J. P., McLeod, D. G., Heidenberg, H. B., Sesterhenn, I. A., Finger, M. J., Moul, J. W., and Srivastava, S. Frequent detection of codon 877 mutation in the androgen receptor gene in advanced prostate cancer. Cancer Res., 54: 2861-2864, 1994.
60. Taplin, M. E., Bubley, G. J., Shuster, T. D., Frantz, M. E., Spooner, A. E., Ogata, G. K., Keer, H. N., and Balk, S. P. Mutation of the androgen-receptor gene in metastatic androgen-independent prostate cancer. N. Engl. J. Med., 332: 1393-1398, 1995.
61. Tilley, W. D., Buchanan, G., Hickey, T. E., and Horsfall, D. J. Detection of androgen receptor mutations in human prostate cancer by immunohistochemistry and SSCP. Proc. Am. Assoc. Cancer Res., 36: 266, 1995.
62. Veldscholte, J., Ris-Stalpers, C., Kuiper, G. G., Jenster, G., Berrevoets, C., Claassen, E., van Rooij, H. C., Trapman, J., Brinkmann, A. O., and Mulder, E. A mutation in the ligand binding domain of the androgen receptor of human LNCaP cells affects steroid binding characteristics and response to anti-androgens. Biochem. Biophys. Res. Commun., 173: 534-540, 1990.
63. Wilding, G., Chen, M., and Gelman, E. P. Aberrant response in vitro of hormone-responsive prostate cancer cells to antiandrogens. Prostate, 14: 103-115, 1989.
64. Figg, W. D., McCall, N. A., Reed, E., and Sartor, O. The in vitro response of four antisteroid receptor agents on the hormone-responsive prostate cancer cell line LNCaP. Oncol. Rep., 2: 295-298, 1995.
65. Figg, W. D., Kroog, G., Duray, P., Walther, M. M., Patronas, N., Sartor, O., and Reed, E. Flutamide withdrawal plus hydrocortisone resulted in clinical complete response in a patient with prostate carcinoma. Cancer, 79: 1964-1968, 1997.