Oral estramustine and cyclophosphamide in patients with metastatic hormone refractory prostate carcinoma: A phase II study

Cancer

Volumn 88, Issue 6, 2000, Pages 1438-1444

  Bracarda, Sergio ^a,b   Tonato, Maurizio ^a   Rosi, Paolo ^a   De Angelis, Verena ^a   Mearini, Ettore ^a   Cesaroni, Stefano ^a   Fornetti, Pierfrancesco ^a   Porena, Massimo ^a  

^a Policlinico Hospital   (Italy)

^b Policlinico Hospital   (Italy)

Author keywords

Cyclophosphamide; Estramustine; Hormone refractory; Prostate carcinoma

Indexed keywords

ANTIANDROGEN; CYCLOPHOSPHAMIDE; ESTRAMUSTINE; PROSTATE SPECIFIC ANTIGEN;

ADULT; AGED; ALOPECIA; ANEMIA; ANGINA PECTORIS; ANOREXIA; ARTICLE; ASTHENIA; BONE PAIN; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; EDEMA; EPIGASTRIC PAIN; HEMATURIA; HORMONE RESISTANCE; HUMAN; LEUKOPENIA; MALE; METASTASIS; NAUSEA; PRIORITY JOURNAL; PROSTATE CARCINOMA; THROMBOCYTOPENIA; VOMITING;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; ANDROGEN ANTAGONISTS; ANTINEOPLASTIC AGENTS, ALKYLATING; ANTINEOPLASTIC AGENTS, HORMONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE NEOPLASMS; CARCINOMA; CHI-SQUARE DISTRIBUTION; CONFIDENCE INTERVALS; CYCLOPHOSPHAMIDE; DISEASE PROGRESSION; ESTRAMUSTINE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PAIN; PROSPECTIVE STUDIES; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; REMISSION INDUCTION; SAFETY;

EID: 0034654510     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0142(20000315)88:6<1438::AID-CNCR23>3.0.CO;2-O     Document Type: Article

References (33)

1. Catalona WJ. Management of cancer of the prostate. N Engl J Med 1994;331:996-1004.
2. Frydenberg M, Stricker PD, Kaye KW. Prostate cancer diagnosis and management. Lancet 1997;349:1681-7.
3. Scher HI, Steineck G, Kelly WK. Hormone-refractory ("D3") prostate cancer: refining the concept. Urology 1995;46:142-8.
4. Scher Hi, Kelly WK. Flutamide withdrawal syndrome: its impact on clinical trials in prostate cancer. J Clin Oncol 1993;11:1566-72.
5. Small EJ, Srinivas S. The antiandrogen withdrawal syndrome: experience in a large cohort of unselected patients with advanced prostate cancer. Cancer 1995;76:1428-34.
6. Eisenberger MA, Simon R, O'Dwyer PJ, Wittes RE, Friedman MA. A re-evaluation of non-hormonal cytotoxic chemotherapy in the treatment of prostatic carcinoma. J Clin Oncol 1985;3:827-41.
7. Tonato M, Bracarda S. The role of chemotherapy in the treatment of prostatic carcinoma. Rays 1993;18:87-93.
8. Vogelzang NJ, Crawford ED, Zietman A for the Consensus Panel. Current clinical trial design issues in hormone-refractory prostate carcinoma. Cancer 1998;82:2093-101.
9. Newling DWW. The management of hormone refractory prostate cancer. Eur Urol 1996;29(s2):69-74.
10. Seidman AD, Scher HI, Petrylak D, Dershaw DD, Curley T. Estramustine and vinblastine: use of prostate specific antigen as a clinical trial end point for hormone refractory prostatic cancer. J Urol 1992;147:931-4.
11. Hudes GR, Greenberg R, Krigel RL, Fox S, Scher R, Litwin S, et al. Phase II study of estramustine and vinblastine, two microtubule inhibitors, in hormone-refractory prostate cancer. J Clin Oncol 1992;10:1754-61.
12. Pienta KJ, Redman B, Hussain M, Cummings G, Esper PS, Appel C, et al. Phase II evaluation of oral estramustine and oral etoposide in hormone-refractory adenocarcinoma of the prostate. J Clin Oncol 1994;12:2005-12.
13. Pienta KJ, Redman BG, Bandekar R, Strawderman M, Cease K, Esper PS, et al. A phase II trial of oral estramustine and oral etoposide in hormone-refractory prostate cancer. Urology 1997;50:401-7.
14. Hudes GR, Nathan F, Khater C, Haas N, Cornfield M, Giantonio B, et al. Phase II trial of 96-hour paclitaxel plus oral estramustine phosphate in metastatic hormone-refractory prostate cancer. J Clin Oncol 1997;15:3156-63.
15. Petrylak DP, Macarthur RB, O'Connor J, Shelton G, Judge T, Balog J, et al. Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer. J Clin Oncol 1999; 17:958-67.
16. Raghavan D, Cox K, Pearson BS, Coorey GJ, Rogers J, Hunter Watt W, et al. Oral cyclophosphamide for the management of hormone-refractory prostate cancer. Br J Urol 1993;72: 625-8.
17. Abell FL, Wilkes JD, Divers L, Huben R, Velagapudi S, Raghavan D. Oral cyclophosphamide (CTX) for hormone refractory prostate cancer (HRPC). Proc Am Soc Clin Oncol 1995; 14:646.
18. Maulard-Durdux C, Dufour B, Hennequin C, Chrétien Y, Delanian S, Housset M. Phase II study of the oral cyclophosphamide and oral etoposide combination in hormone-refractory prostate carcinoma patients. Cancer 1996;77:1144-8.
19. Taylor CD, Elson P, Trump DL. Importance of continued testicular suppression in hormone-refractory prostate cancer. J Clin Oncol 1993;11:2167-72.
20. Van Poppel H, Werbrouck PW, Baert L. Effect of estramustine phosphate on free androgens. Acta Urol Belg 1990;58: 89-95.
21. Kelly WK, Scher HI, Mazumdar M, Vlamis V, Schwartz M, Fossa SD. Prostate-specific antigen as a measure of disease outcome in metastatic hormone-refractory prostate cancer. J Clin Oncol 1993;11:607-15.
22. Smith DC, Pienta KJ. The use of prostate-specific antigen as a surrogate end point in the treatment of patients with hormone refractory prostate cancer. Urol Clin North Am 1997;24(2):433-7.
23. Tannock I, Gospodarowicz M, Meakin W, Panzarella T, Stewart L, Rider W. Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response. J Clin Oncol 1989;7: 590-7.
24. World Health Organization. Handbook for reporting results of cancer treatment. WHO Offset Pub. No. 48. Geneva: World Health Organization, 1979.
25. Marubini E, Valsecchi MG. Analysing survival data from clinical trials and observational studies. Chichester: John Wiley & Sons Ltd., 1995.
26. Plowman PN, Perry LA, Chard T. Androgen suppression by hydrocortisone without aminoglutethimide in orchiectomised men with prostatic cancer. Br J Urol 1987;59:255-7.
27. Newling DWW, Denis L, Vermeylen K. Orchiectomy versus goserelin and flutamide in the treatment of newly diagnosed metastatic prostate cancer. Cancer 1993;72:3793-8.
28. Storlie JA, Buckner JC, Wiseman GA, Burch PA, Hartmann LC, Richardson RL. Prostate specific antigen levels and clinical response to low dose dexamethasone for hormone-refractory metastatic prostate cancer. Cancer 1995;76:96-100.
29. Yagoda A, Petrylak D. Cytotoxic chemotherapy for advanced hormone-resistant prostate cancer. Cancer 1993;71:1098-109.
30. Iversen P, Rasmussen F, Asmussen C, Christensem IJ, Eickhoff J, Klarskov P, et al. Estramustine phosphate versus placebo as second line treatment after orchiectomy in patients with metastatic prostate cancer: DAPROCA study 9002. J Urol 1997;157:929-34.
31. Moore MJ, Osoba D, Murphy K, Tannock IF, Armitage A, Findlay B, et al. 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 1994;12:689-94.
32. Tannock IF, Osoba D, Stockier MR, Ernst DS, Neville AJ, Moore MJ, et al. 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 1996;14:1756-64.
33. Eisenberger MA, Nelson WG. How much can we rely on the level of PSA as an endpoint for evaluation of clinical trials? A word of caution! J Natl Cancer Inst 1996;88:779-81.