Phase II trial of tesmilifene plus mitoxantrone and prednisone for hormone refractory prostate cancer: High subjective and objective response in patients with symptomatic metastases

Journal of Urology

Volumn 174, Issue 5, 2005, Pages 1808-1813

  Raghavan, D ^a   Brandes, L J ^b   Klapp, K ^b   Snyder, T ^b   Styles, E ^b   Tsao Wei, D ^b   Lieskovsky, G ^b   Quinn, D I ^b   Ramsey, E W ^b  

^a TAUSSIG CANCER INSTITUTE   (United States)

^b NONE

Author keywords

1,2 dipalmitoyl 3 phosphatidylethanolamine; Mitoxantrone; Prostate; Prostatic neoplasms; Quality of life

Indexed keywords

ANALGESIC AGENT; LORAZEPAM; METOCLOPRAMIDE; MITOXANTRONE; NARCOTIC ANALGESIC AGENT; ONDANSETRON; PREDNISOLONE; PROSTATE SPECIFIC ANTIGEN; TESMILIFENE;

ADULT; AGED; AGEUSIA; AGITATION; AKATHISIA; ALOPECIA; ANALGESIA; ANOREXIA; ANXIETY; ARTICLE; ASTHENIA; ATAXIA; BLEEDING; BONE METASTASIS; BONE PAIN; BREATHING DISORDER; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PAIN; CANCER SURVIVAL; CARDIOTOXICITY; CARDIOVASCULAR DISEASE; CELLULITIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONFUSION; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DEPRESSION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; ECCHYMOSIS; EXFOLIATIVE DERMATITIS; FATIGUE; FEVER; FLATULENCE; GASTRITIS; HALLUCINATION; HEADACHE; HEART FAILURE; HUMAN; HYPERGLYCEMIA; HYPOTENSION; INSOMNIA; LEUKOPENIA; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MALE; METASTASIS; MOTION SICKNESS; MOTOR DYSFUNCTION; MYASTHENIA; NAIL DISEASE; NAUSEA; PAIN; PARESTHESIA; PERSONALITY DISORDER; PHASE 2 CLINICAL TRIAL; PHLEBITIS; PRIORITY JOURNAL; PROSTATE CANCER; QUALITY OF LIFE; SENSORY DYSFUNCTION; SIDE EFFECT; SOMNOLENCE; STOMATITIS; SWEATING; TASTE DISORDER; THROMBOCYTOPENIA; TOOTH DISEASE; TREMOR; URINE INCONTINENCE; VASCULAR DISEASE; VASODILATATION; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION; XEROSTOMIA;

EID: 27544460164     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ju.0000176799.63184.99     Document Type: Article

References (20)

1. Beer, T. M. and Raghavan, D.: Chemotherapy for hormone-refractory prostate cancer: beauty is in the eye of the beholder. Prostate, 45: 184, 2000
2. Osborne, C. K., Drelichman, A., Von Hoff, D. D. and Crawford, E. D.: Mitoxantrone: modest activity in a phase II trial in advanced prostate cancer. Cancer Treat Rep, 67: 1133, 1983
3. Raghavan, D., Coorey, G., Rosen, M., Page, J. and Farebrother, T.: Management of hormone-resistant prostate cancer: an Australian trial. Semin Oncol, suppl., 23: 20, 1996
4. Tannock, I. F., Osoba, D., Stockier, M. R., Ernst, D. S., Neville, A. J., Moore, M. J. 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, 14: 1756, 1996
5. Kantoff, P. W., Halabi, S., Conaway, M., Picus, J., Kirshner, J., Hars, V. 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, 17: 2506, 1999
6. Ernst, D. S., Tannock, I. F., Winquist, E. W., Venner, P. M., Reyno, L., Moore, M. J. et al: Randomized, double-blind, controlled trial of mitoxantrone/prednisone and clodronate versus mitoxantrone/prednisone and placebo in patients with hormone-refractory prostate cancer and pain. J Clin Oncol, 21: 3335, 2003
7. Brandes, L. J., Bogdanovic, R. P., Cawker, M. D. and LaBella, F. S.: Histamine and growth: interaction of antiestrogen binding site ligands with a novel histamine site that may be associated with calcium channels. Cancer Res, 47: 4025, 1987
8. Brandes, L. J., Queen, G. M. and LaBella, F. S.: N,N-diethyl-2-[4- (phenylmethyl)phenoxy] ethanamine (DPPE) a chemopotentiating and cytoprotective agent in clinical trials: interaction with histamine at cytochrome P450 3A4 and other isozymes that metabolize antineoplastic drugs. Cancer Chemother Pharmacol, 45: 298, 2000
9. Brandes, L. J., La Bella, F. S. and Warrington, R. C.: Increased therapeutic index of antineoplastic drugs in combination with intracellular histamine antagonists. J Natl Cancer Inst, 83: 1329, 1991
10. Brandes, L. J., Bracken, S. P. and Ramsey, E. W.: N, N-diethyl-2-[4- (phenylmethyl) phenoxy [ethanamine in combination with cyclophosphamide: an active low-toxicity regimen for metastatic hormonally unresponsive prostate cancer. J Clin Oncol, 13: 1398, 1995
11. Brandes, L. J. and Bracken, S. P.: The intracellular histamine antagonist, N,N-diethyl-2-[4-(phenylmethyl)phenoxy] ethamine HCL, may potentiate doxorubicin in the treatment of metastatic breast cancer: results of a pilot study. Breast Cancer Res Treat, 49: 61, 1998
12. Reyno, L., Seymour, L., Tu, D., Dent, S., Gelmon, K., Walley, B. et al: Phase III study of N, N-diethyl-2-[4-(phenylmethyl) phenoxy]ethanamine (BMS-217380-01) combined with doxorubicin versus doxorubicin alone in metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA. 19. J Clin Oncol, 22: 269, 2004
13. Ferguson, P. J. and Vincent, M. D.: Enhancement of docetaxel cytotoxicity in multidrug resistant variant cell lines of human head and neck squamous cell carcinoma HN-5a and promyelocytic leukemia HL-60 by N, N-diethyl-2- [4(phenylmethyl)phenoxy] ethanamine (DPPE, Tesmilifene). Proc Am Assoc Cancer Res, 39:3462, abstract, 1998
14. Menendez, A. T., Raventos-Suarez, C. and Fairchild, C.: Mechanism of action of DPPE, a chemosensitizing agent. Proc Am Assoc Cancer Res, 39: 3462, abstract, 1998
15. Boureau, F., Luu, M. and Doubrere, J. F.: Comparative study of the validity of four French McGill Pain Questionnaire (MPQ) versions. Pain, 50: 59, 1992
16. Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J. et al: The European Organization for Research and Treatment of Cancer QLQ-30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst, 85: 365, 1993
17. King, M. T.: The interpretation of scores from the EORTC quality-of-life questionnaire QLQ-C30. Qual Life Res, 5: 555, 1996
18. Walters, S. J., Campbell, M. J. and Lall, R.: Design and analysis of trials with quality of life as an outcome: a practical guide. J Biopharm Stat, 11: 155, 2001
19. Bubley, G. J., Carducci, M., Dahut, W., Dawson, N., Daliani, D., Eisenberger, M. 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, 17: 3461, 1999
20. Berry, W., Dakhil, S., Modiano, M., Gregurich, M. and Asmar, L.: Phase III study of mitoxantrone plus low dose prednisone versus low dose prednisone alone in patients with asymptomatic hormone refractory prostate cancer. J Urol, 168: 2439, 2002