Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma

Journal of Clinical Oncology

Volumn 17, Issue 9, 1999, Pages 2745-2751

  Chapman, Paul B ^a   Einhorn, Lawrence H ^a   Meyers, Michael L ^a   Saxman, Scott ^a   Destro, Alicia N ^a   Panageas, Katherine S ^a   Begg, Colin B ^a   Agarwala, Sanjiv S ^a   Schuchter, Lynn M ^a   Ernstoff, Marc S ^a   Houghton, Alan N ^a   Kirkwood, John M ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARMUSTINE; CISPLATIN; DACARBAZINE; DEXAMETHASONE; GRANISETRON; METOCLOPRAMIDE; ONDANSETRON; TAMOXIFEN;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BONE MARROW SUPPRESSION; CANCER COMBINATION CHEMOTHERAPY; CANCER REGRESSION; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; FATIGUE; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MELANOMA; METASTASIS; MULTICENTER STUDY; NAUSEA; ORAL DRUG ADMINISTRATION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VOMITING;

EID: 0032858487     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.1999.17.9.2745     Document Type: Article

References (34)

1. Stadelmann WK, Rapaport DP, Soong S-J, et al: Prognostic clinical and pathological features, in Balch CM, Houghton AN, Sober AJ, et al (eds): Cutaneous Melanoma (ed 3). St. Louis, MO, Quality Medical Publishing, Inc, 1998, pp 11-36
2. Sirott MN, Bajorin DF, Wong GYC, et al: Prognostic factors in patients with metastatic melanoma: A multivariate analysis. Cancer 72:3091-3098, 1993
3. Hill GJ II, Krementz ET, Hill HZ: Dimethyl triazeno imidazole carboxamide and combination therapy for melanoma: IV. Late results after complete response to chemotherapy. Cancer 53:1299-1305, 1984
4. Nathanson L, Kaufman SD, Carey RW: Vinblastine infusion, bleomycin and cis-dichlorordiamine-platinum chemotherapy in metastatic melanoma. Cancer 48:1290-1298, 1981
5. Legha SS, Ring S, Papadopoulos N, et al: A prospective evaluation of a triple-drug regimen containing cisplatin, vinblastine, and dacarbazine (CVD) for metastatic melanoma. Cancer 64:2024-2029, 1989
6. Portlock CS, Murren J, Buzaid A, et al: High dose cisplatin and dacarbazine in metastatic melanoma. Proc Am Soc Clin Oncol 8:284, 1989 (abstr 1107)
7. Seigier HF, Lucas VS Jr, Pickett NJ, et al: DTIC, CCNU, bleomycin and vincristine (BOLD) in metastatic melanoma. Cancer 46:2346-2348, 1980
8. Rosenberg SA, Lotze MT, Muul LA, et al: Observations on the systemic administration of autologous lymphokine-activated killer cells and recombinant interleukin-2 to patients with metastatic cancer. N Engl J Med 313:1485-1492, 1985
9. National Cancer Institute of Canada Melanoma Group: Vinblastine, bleomycin, and cis-platinum for the treatment of metastatic malignant melanoma. J Clin Oncol 2:131-134, 1984
10. Steffens T, Bajorin D, Chapman P, et al: A phase II trial of high dose cisplatin and dacarbazine. Cancer 68:1230-1237, 1991
11. Luger SM, Kirkwood JM, Ernstoff MS, et al: High-dose cisplatin and dacarbazine in the treatment of metastatic melanoma. J Natl Cancer Inst 82:1934-1937, 1990
12. York R, Foltz A: Bleomycin, vincristine, lomustine, and DTIC chemotherapy for metastatic melanoma. Cancer 61:2183-2186, 1988
13. The Prudente Foundation Melanoma Study Group: Chemotherapy of disseminated melanoma with bleomycin, vincristine, CCNU, and DTIC (BOLD regimen). Cancer 63:1676-1680, 1989
14. Rosenberg SA, Lotze MT, Yang JC, et al: Prospective randomized trial of high-dose interleukin-2 alone or in conjunction with lymphokine-activated killer cells for the treatment of patients with advanced cancer. J Natl Cancer Inst 85:622-632, 1993 (erratum appears in J Natl Cancer Inst 85:1091, 1993)
15. Luikart SD, Kennealey GT, Kirkwood JM: Randomized phase III trial of vinblastine, bleomycin, and cis-dichlorodiammine-platinum versus dacarbazine in malignant melanoma. J Clin Oncol 2:164-168, 1984
16. Buzaid AC, Legha S, Winn R, et al: Cisplatin, vinblastine, and dacarbazine versus dacarbazine alone in metastatic melanoma: Preliminary results of a phase III Cancer Community Oncology Program trial. Proc Am Soc Clin Oncol 12:389, 1993 (abstr 1328)
17. Del Prete SA, Maurer LH, O'Donnell J, et al: Combination chemotherapy with cisplatin, carmustine, dacarbazine, and tamoxifen in metastatic melanoma. Cancer Treat Rep 68:1403-1405, 1984
18. McClay EF, Mastrangelo MJ, Berd D, et al: Effective combination chemo/hormonal therapy for malignant melanoma: Experience with three consecutive trials. Int J Cancer 50:553-556, 1992
19. Saba HI, Cruse CW, Wells KE, et al: Treatment of stage IV malignant melanoma with dacarbazine, carmustine, cisplatin, and tamoxifen regimens: A University of South Florida and H. Lee Moffitt Melanoma Center study. Ann Plast Surg 28:65-69, 1992
20. Lattanzi SC, Tosteson T, Chertoff J, et al: Dacarbazine, cisplatin and carmustine, with or without tamoxifen, for metastatic melanoma: 5-year follow-up. Melanoma Res 5:365-369, 1995
21. Richards JM, Gilewski TA, Ramming K, et al: Effective chemotherapy for melanoma after treatment with interleukin-2. Cancer 69:427-429, 1992
22. Zelen M: The randomization and stratification of patients to clinical trials. J Chronic Dis 27:365-375, 1974
23. Creekmore SP, Longo DL, Urba WJ: Principles of the clinical evaluation of biologic agents, in DeVita VTJ, Hellman S, Rosenberg SA (eds): Biologic Therapy of Cancer. Philadelphia, PA, JB Lippincott, 1991, pp 67-86
24. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
25. Mantel N: Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50:163-170, 1966
26. Cocconi G, Bella M, Calabresi F, et al: Treatment of metastatic malignant melanoma with dacarbazine plus tamoxifen. N Engl J Med 327:516-523, 1992
27. Mitchell MS, Von Eschen KB: Phase III trial of melacine melanoma theraccine versus combination chemotherapy in the treatment of stage IV melanoma. Proc Am Soc Clin Oncol 16:494a, 1997 (abstr 1778)
28. Margolin KA, Liu PY, Flaherty LE, et al: Phase II study of carmustine, dacarbazine, cisplatin, and tamoxifen in advanced melanoma: A Southwest Oncology Group study. J Clin Oncol 16:664-669, 1998
29. Rusthoven JJ, Quirt IC, Iscoe NA, et al: Randomized, double-blind, placebo-controlled trial comparing the response rates of carmustine, dacarbazine, and cisplatin with and without tamoxifen in patients with metastatic melanoma: National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 14:2083-2090, 1996
30. Chiarion Sileni V, Nortilli R, Medici M, et al: BCNU (B), cisplatin (C), dacarbazine (D) and tamoxifen (T) (BCDT) in metastatic melanoma (MM): Results of a randomized phase II study (Meeting abstract). Proc Am Soc Clin Oncol 16:495a, 1997 (abstr 1782)
31. Keilholz U, Stoter G, Punt CJ, et al: Recombinant interleukin-2-based treatments for advanced melanoma: The experience of the European Organization for Research and Treatment of Cancer Melanoma Cooperative Group. Cancer J Sci Am 3:S22-S28, 1997 (suppl 1)
32. McClay EF, McClay MET: Tamoxifen: Is it useful in the treatment of patients with metastatic melanoma? J Clin Oncol 12:617-626, 1994
33. Legha SS, Ring S, Bedikian A, et al: Treatment of metastatic melanoma with combined chemotherapy containing cisplatin, vinblastine and dacarbazine (CVD) and biotherapy using interleukin-2 and interferon-alpha. Ann Oncol 7:827-835, 1996
34. McDermott DF, Mier JW, Lawrence DP, et al: A phase II pilot trial of concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine (CVD), interleukin-2 (IL-2), and interferon alpha-2B (IFN) in patients with metastatic melanoma. Proc Am Soc Clin Oncol 17:507a, 1998 (abstr 1956)