A phase II study of estramustine, docetaxel, and exisulind in patients with hormone-refractory prostate cancer: Results of cancer and leukemia group B trial 90004

Clinical Genitourinary Cancer

Volumn 6, Issue 2, 2008, Pages 110-116

  Dawson, Nancy A ^a,k   Halabi, Susan ^b,c   Ou, San San ^b   Biggs, David D ^d   Kessinger, Anne ^e   Vogelzang, Nicholas ^f   Clamon, Gerald H ^g   Nanus, David M ^h   Kelly, W Kevin ⁱ   Small, Eric J ^j  

^a GEORGETOWN UNIVERSITY   (United States)

^b Statistical Center   (United States)

^c DUKE UNIVERSITY   (United States)

^d CHRISTIANA CARE HEALTH SYSTEM   (United States)

^e UNIVERSITY OF NEBRASKA AT OMAHA   (United States)

^f NEVADA CANCER INSTITUTE   (United States)

^g UNIVERSITY OF IOWA   (United States)

^h WEILL CORNELL MEDICAL COLLEGE   (United States)

ⁱ YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j UNIVERSITY OF CALIFORNIA   (United States)

^k GEORGETOWN UNIVERSITY   (United States)

more..

Author keywords

Deep vein thrombosis; Progressionfree survival; Prostate specific antigen; Selective apoptotic antineoplastic drug

Indexed keywords

BEVACIZUMAB; DEXAMETHASONE; DOCETAXEL; ESTRAMUSTINE; PROSTATE SPECIFIC ANTIGEN; SULINDAC SULFONE; WARFARIN; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; SULINDAC; TAXOID;

ADD ON THERAPY; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALLERGIC REACTION; ALOPECIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; ATRIOVENTRICULAR JUNCTION ARRHYTHMIA; BILIRUBIN BLOOD LEVEL; BRAIN HEMORRHAGE; CANCER CHEMOTHERAPY; CARDIOVASCULAR DISEASE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONFUSION; CONSTIPATION; COUGHING; CREATININE BLOOD LEVEL; DEHYDRATION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; DYSPNEA; EMBOLISM; EPISTAXIS; EYE DISEASE; FATIGUE; FEBRILE NEUTROPENIA; FEVER; GRANULOCYTE; HAIR LOSS; HEART ARREST; HEART ATRIUM FIBRILLATION; HEART ATRIUM FLUTTER; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HEART SUPRAVENTRICULAR ARRHYTHMIA; HEARTBURN; HEMATURIA; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; HYPERSENSITIVITY; HYPOCALCEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; HYPOTENSION; LETHARGY; LEUKEMIA; MAJOR CLINICAL STUDY; MALAISE; MALE; MOOD DISORDER; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; NAIL; NAUSEA; NEUROPATHY; NEUTROPHIL; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PROGRESSION FREE SURVIVAL; PROPHYLAXIS; PROSTATE ADENOCARCINOMA; SIDE EFFECT; SOMNOLENCE; STOMATITIS; SURVIVAL TIME; TASTE DISORDER; TEAR; THROMBOCYTE; THROMBOEMBOLISM; THROMBOSIS; VOMITING; WOUND INFECTION; CHEMICALLY INDUCED DISORDER; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; DRUG RESISTANCE; MIDDLE AGED; PROSTATE TUMOR; SURVIVAL;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; ESTRAMUSTINE; HUMANS; MALE; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; SULINDAC; SURVIVAL ANALYSIS; TAXOIDS; THROMBOEMBOLISM;

EID: 58149192808     PISSN: 15587673     EISSN: None     Source Type: Journal    
DOI: 10.3816/CGC.2008.n.017     Document Type: Article

References (29)

1. Jemal A, Siegel R, Ward E, et al. Cancer statistics 2007. CA Cancer J Clin 2007; 57: 43-66.
2. (Pubitemid 26171141) Robson M, Dawson N. How is androgen-dependent prostate cancer best treated? Hematol Oncol Clin North Am 1996; 10: 727-47.
3. (Pubitemid 23049638) Yagoda A, Petrylak D. Cytotoxic chemotherapy for advanced hormoneresistant prostate cancer. Cancer 1993; 71: 1098-109.
4. Eisenberger MA, Kennedy P, Abrams J. How effective is cytotoxic chemotherapy for disseminated prostatic carcinoma? Oncology (Huntington) 1987; 1: 59-71.
5. Tannock IF, deWit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351: 1502-12.
6. (Pubitemid 23304382) Dahllof B, Billstrom A, Cabral F, et al. Estramustine depolymerizes microtubules by binding to tubulin. Cancer Res 1993; 53: 4573-81.
7. (Pubitemid 29090589) Kreis W, Budman DR, Fetten J, et al. Phase I trial of the combination of daily estramustine phosphate and intermittent docetaxel in patients with metastatic hormone refractory prostate carcinoma. Ann Oncol 1999; 10: 33-8.
8. (Pubitemid 30000739) 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) : 14-8.
9. Petrylak DP, Macarthur RB, O'Connor J, et al. Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer. J Clin Oncol 1999; 17: 958-67.
10. Savarese DM, Halabi S, Hars V, et al. Phase II study of docetaxel, estramustine and low-dose hydrocortisone in men with hormone-refractory prostate cancer: a final report of CALGB 9780. Cancer and Leukemia Group B. J Clin Oncol 2001; 19: 2509-16.
11. Oh WK, Halabi S, Kely WK, et al. A phase II study of estramustine, docetaxel and carboplatin with granulocyte-colony stimulating factor support in patient with hormone-refractory prostate cancer. Cancer and Leukemia Group B 99813. Cancer 2003; 98: 2592-8.
12. Picus J, Halabi S, Rini B, et al. The use of bevacizumab (B) with docetaxel (D) and estramustine (E) in hormone refractory prostate cancer (HRPC) : initial results of CALGB 90006. Proc Am Soc Clin Oncol 2003; 22: 393 (Abstract 1578).
13. (Pubitemid 26185452) 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: 1756-64.
14. (Pubitemid 29368252) 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: 2506-13.
15. Goluboff ET. Exisulind, a selective apoptotic antineoplastic drug. Expert Opin Investig Drugs 2001; 10: 1875-82.
16. Lim JT, Piazza GA, Han EK, et al. Sulindac derivatives inhibit growth and induce apoptosis in human prostate cancer cell lines. Biochem Pharmacol 1999; 58: 1097-107.
17. (Pubitemid 29063347) Goluboff ET, Shabsigh A, Saidi JA, et al. Exisulind (sulindac sulfone) suppresses growth of human prostate cancer in a nude mouse xenograft model by increasing apoptosis. Urology 1999; 53: 440-5.
18. (Pubitemid 37323304) Lim JT, Piazza GA, Pamukcu R, et al. Exisulind and related compounds inhibit expression and function of the androgen receptor in human prostate cancer cells. Clin Cancer Res 2003; 9: 4972-82.
19. (Pubitemid 30035640) Soriano AF, Helfrich B, Chan DC, et al. Synergistic effects of new chemopreventative and conventional cytotoxic agents against human lung cancer cell lines. Cancer Res 1999; 59: 6178-84.
20. (Pubitemid 32750972) Goluboff ET, Prager D, Rukstalis D, et al. Safety and efficacy of exisulind for treatment of recurrent prostate cancer following radical prostatectomy. J Urol 2001; 166: 882-6.
21. Thereasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205-16.
22. (Pubitemid 29517916) 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: 3461-7.
23. Kaplan E, Meier P. Nonparametric estimations from incomplete observations. J Am Stat Assoc 1958; 53: 457-81.
24. 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: 1513-20.
25. (Pubitemid 30064979) Van Stolk R, Stoner G, Hayton WL, et al. Phase I trial of exisulind (sulindac, sulfone, FGN-1) as a chemopreventive agent in patients with familial adenomatous polyposis. Clin Cancer Res 2000; 6: 78-89.
26. Witta SE, Gustafson DL, Pierson AS, et al. A phase I and pharmacokinetic study of exisulind and docetaxel in patients with advanced solid tumors. Clin Cancer Res 2004; 10: 7229-37.
27. Ryan CW, Stadler WM, Vogelzang NJ. Phase I/II dose-escalation study of exisulind and docetaxel in patients with hormone-refractory prostate cancer. BJU Int 2005; 95: 963-8.
28. Sinibaldi VJ, Elza-Brown K, Schmidt J, et al. Phase II evaluation of docetaxel plus exisulind in patients with androgen independent prostate carcinoma. Am J Clin Oncol 2006; 29: 395-8.
29. (Pubitemid 32522115) Johnson JI, Decker S, Zaharevitz D, et al. Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials. Br J Cancer 2001; 84: 1424-31.