Phase II study of mitoxantrone and ketoconazole for hormone-refractory prostate cancer

Cancer

Volumn 106, Issue 11, 2006, Pages 2459-2465

  Eklund, John ^a   Kozloff, Mark ^b,c   Vlamakis, Joy ^b   Starr, Alexander ^b   Mariott, Margaret ^b   Gallot, Lilia ^a   Jovanovic, Borko ^a   Schilder, Lawrence ^d   Robin, Erwin ^e   Pins, Michael ^a   Bergan, Raymond C ^a,f  

^a NORTHWESTERN UNIVERSITY   (United States)

^b Ingalls Memorial Hospital   (United States)

^c Jr Hospital of Cook County   (United States)

^d Silver Cross Hospital   (United States)

^e UNIVERSITY OF MÜNSTER   (Germany)

^f NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Chemotherapy; Hormone refractory; Metastasis; Phase II; Prostate cancer

Indexed keywords

ANTIANDROGEN; ASCORBIC ACID; HYDROCORTISONE; KETOCONAZOLE; MITOXANTRONE; PROSTATE SPECIFIC ANTIGEN; TESTOSTERONE;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; BLOOD CLOTTING DISORDER; BONE DISEASE; CANCER GROWTH; CANCER REGRESSION; CANCER SURVIVAL; CASTRATION; CLINICAL TRIAL; COHORT ANALYSIS; DEEP VEIN THROMBOSIS; DIARRHEA; DIZZINESS; DRUG WITHDRAWAL; EDEMA; ELECTROCORTICOGRAPHY; FATIGUE; FEBRILE NEUTROPENIA; GLEASON SCORE; HEART ATRIUM ARRHYTHMIA; HEART FUNCTION; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOKALEMIA; INFECTION; INSOMNIA; KIDNEY DISEASE; LEUKOPENIA; LUNG DISEASE; MAJOR CLINICAL STUDY; MALAISE; MALE; METASTASIS; NAIL DISEASE; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PAIN; PERFORMANCE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; RASH; SIDE EFFECT; SOFT TISSUE DISEASE; SYNCOPE; THROMBOCYTOPENIA; VOMITING; WEIGHT REDUCTION; XEROSTOMIA;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; HUMANS; KETOCONAZOLE; MALE; MIDDLE AGED; MITOXANTRONE; NEOPLASMS, HORMONE-DEPENDENT; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 33646893662     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.21880     Document Type: Article

References (36)

1. Jemal A, Murray T, Ward E, et al. Cancer statistics, 2005. C4 Cancer J Clin. 2005;55:10-30.
2. Martel C, Gumerlock P, Meyers F, Lara P. Current strategies in the management of hormone refractory prostate cancer. Cancer Treat Rev. 2003;29:171-187.
3. Savarese D, Taplin ME, Halabi S, Hars V, Kreis W, Vogelzang N. A phase II study of docetaxel (Taxotere), estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: preliminary results of cancer and leukemia group B Trial 9780. Semin Oncol. 1999;26(5 suppl 17):39-44.
4. Sinibaldi VJ, Carducci M, Laufer M, Eisenberger M. Preliminary evaluation of a short course of estramustine phosphate and docetaxel (Taxotere) in the treatment of hormone-refractory prostate cancer. Semin Oncol. 1999;26(5 suppl 17):45-48.
5. Hudes GR, Nathan F, Khater C, et al. Phase II trial of 96-hour paclitaxel plus oral estramustine phosphate in metastatic hormone-refractory prostate cancer. J Clin Oncol. 1997;15:3156-3163.
6. Friedland D, Cohen J, Miller R Jr., et al. A phase II trial of docetaxel (Taxotere) in hormone-refractory prostate cancer: correlation of antitumor effect to phosphorylation of Bcl-2. Semin Oncol. 1999;26(5 suppl 17):19-23.
7. Picus J, Schultz M. Docetaxel (Taxotere) as monotherapy in the treatment of hormone-refractory prostate cancer: preliminary results. Semin Oncol. 1999;26(5 suppl 17):14-18.
8. Di Lorenzo G, Pizza C, Autorino R, et al. Weekly docetaxel and vinorelbine (VIN-DOX) as first line treatment in patients with hormone refractory prostate cancer. Eur Urol. 2004;46:712-716.
9. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351:1513-1520.
10. 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;351:1502-1512.
11. Ferrero JM, Foa C, Thezenas S, et al. A weekly schedule of docetaxel for metastatic hormone-refractory prostate cancer. Oncology. 2004;66:281-287.
12. Dahut WL, Gulley JL, Arlen PM, et al. Randomized phase II trial of docetaxel plus thalidomide in androgen-independent prostate cancer. J Clin Oncol. 2004;22:2532-2539.
13. Sella A, Kilbourn R, Amato R, et al. Phase II study of ketoconazole combined with weekly doxorubicin in patients with androgen-independent prostate cancer. J Clin Oncol. 1994;12:683-688.
14. Johnson DE, Babaian RJ, von Eschenbach AC, Wishnow KI, Tenney D. Ketoconazole therapy for hormonally refractive metastatic prostate cancer. Urology. 1988;31:132-134.
15. Eichenberger T, Trachtenberg J. Effects of high-dose ketoconazole on patients who have androgen-independent prostatic cancer. Can J Surg. 1989;32:349-352.
16. Small EJ, Baron AD, Fippin L, Apodaca D. Ketoconazole retains activity in advanced prostate cancer patients with progression despite flutamide withdrawal. J Urol. 1997;157:1204-1207.
17. Harris KA, Weinberg V, Bok RA, Kakefuda M, Small EJ. Low dose ketoconazole with replacement doses of hydrocortisone in patients with progressive androgen independent prostate cancer. J Urol. 2002;168:542-545.
18. Wilkinson S, Chodak G. An evaluation of intermediate-dose ketoconazole in hormone refractory prostate cancer. Eur Urol. 2004;45:581-584; discussion, 85.
19. Small EJ, Halabi S, Dawson NA, et al. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol. 2004;22:1025-1033.
20. Figg WD, Liu Y, Arlen P, et al. A randomized, phase II trial of ketoconazole plus alendronate versus ketoconazole alone in patients with androgen independent prostate cancer and bone metastases. J Urol. 2005;173:790-796.
21. Pont A, Williams PL, Azhar S, et al. Ketoconazole blocks testosterone synthesis. Arch Intern Med. 1982;142:2137-2140.
22. Eichenberger T, Trachtenberg J, Toor P, Keating A. Ketoconazole: a possible direct cytotoxic effect on prostate carcinoma cells. J Urol. 1989;141:190-191.
23. Fisher GR, Patterson LH. Lack of involvement of reactive oxygen in the cytotoxicity of mitoxantrone, CI941 and ametantrone in MCF-7 cells: comparison with doxorubicin. Cancer Chemother Pharmacol. 1992;30:451-458.
24. Allen A. The cardiotoxicity of chemotherapeutic drugs. Semin Oncol. 1992;19:529-542.
25. Tannock IF, Osoba D, Stockler MR, 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;14:1756-1764.
26. 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;17:3461-3467.
27. Bergan RC, Reed E, Myers CE, et al. A phase II study of high dose tamoxifen in patients with hormone refractory prostate cancer. Clin Cancer Res. 1999;5:2366-2373.
28. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10:1-10.
29. Atkinson EN, Brown BW. Confidence limits for probability of response in multistage phase II clinical trials. Biometrics. 1985;41:741-744.
30. Kaplan E, Meier P. Non-parametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-458.
31. Linehan WM, Zbar B, Leach F, Cordon-Cardo C, Isaacs W. Cancers of the genitourinary system. In: DeVita VT, Hellman S, Rosenberg SA, editors. Cancer: principals and practice of oncology. New York Lippincott Williams & Wilkins; 2001:1343-1361.
32. Kantoff PW, Halabi S, Conaway M, et al. Hydrocortisone with or without mitoxantrone in men with hormone-refractory prostate cancer: results of the cancer and leukemia group B 9182 study. J Clin Oncol. 1999;17:2506-2513.
33. Williams G, Kerle DJ, Ware H, et al. Objective responses to ketoconazole therapy in patients with relapsed progressive prostatic cancer. Br J Urol. 1986;58:45-51.
34. Trump DL, Havlin BCH, Messing EM, Cummings KB, Lange PH, Jordan VC. High-dose ketoconazole in advanced hormone-refractory prostate cancer: endocrinologic and clinical effects. J Clin Oncol. 1989;7:1093-1098.
35. Odrazka K, Vaculikova M, Petera J, et al. Bi-weekly epirubicin, etoposide and low-dose dexamethasone for hormone-refractory prostate cancer. Int J Urol. 2003;10:387-391.
36. Neri B, Cipriani G, Fulignati C, et al. Weekly paclitaxel and epirubicin in the treatment of symptomatic hormone-refractory advanced prostate carcinoma: report of a phase II trial. Anticancer Drugs. 2005;16:63-66.