This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Millikan, R. Articles by Logothetis, C. J. Search for Related Content PubMed PubMed Citation Articles by Millikan, R. Articles by Logothetis, C. J. Social Bookmarking                            What's this?

Randomized, Multicenter, Phase II Trial of Two Multicomponent Regimens in Androgen-Independent Prostate Cancer

Randall Millikan, Peter F. Thall, Sang-Joon Lee, Donnah Jones, M.W. Cannon, J. Phillip Kuebler, James Wade, III, Christopher J. Logothetis

From the Genitourinary Medical Oncology Department and Department of Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX; Cancer Center of Wichita/Clinical Community Oncology Program, Wichita, KS; Cancer Center of Columbus/Clinical Community Oncology Program, Columbus, OH; and Central Illinois Clinical Community Oncology Program, Decatur, IL.

Address reprint requests to Randall Millikan, PhD, MD, Department of Genitourinary Medical Oncology, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 427, Houston, TX 77004-4009; email: rmillika{at}notes.mdacc.tmc.edu.

Purpose: Several multicomponent regimens have been reported to be useful in advanced androgen-independent prostate cancer. We used a randomized phase II design to evaluate and compare two such regimens. Patients were accrued primarily in the community setting.

Patients and Methods: Patients with progressive, androgen-independent prostate cancer were randomly assigned to one of two treatments: either ketoconazole/doxorubicin alternating with vinblastine/estramustine (KA/VE) or paclitaxel, estramustine, and oral etoposide (TEE). Patients were prospectively stratified on the basis of disease volume. The primary end points were response and overall survival time.

Results: A total of 75 patients were registered; 71 are included in the analysis. By the criterion of an 80% prostate-specific antigen reduction maintained for at least 8 weeks, 11 (30%) of 37 patients in the TEE arm responded, whereas 11 (32%) of 34 assigned to KA/VE responded. Median survival was 16.9 months (95% confidence interval [CI], 10.5 to 21.2 months) in the TEE arm and 23.4 months (95% CI, 12.9 to 30.6 months) for patients treated with KA/VE. Many patients (24%) failed to complete at least 6 weeks of therapy, including five (8%) treatment-related early deaths.

Conclusion: Each of these regimens produced clinically significant responses, and the observed median survival (18.9 months for all 71 patients) compares favorably with previously published results, especially in the community setting. Nonetheless, it is apparent that these first-generation regimens must be applied judiciously, and thus we view efforts at better patient selection and the development of more tolerable therapies as higher priorities than carrying either of these regimens to phase III evaluation in the cooperative group setting.

Supported by grant no. CA45809 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				Y. Eberhard, S. P. McDermott, X. Wang, M. Gronda, A. Venugopal, T. E. Wood, R. Hurren, A. Datti, R. A. Batey, J. Wrana, et al. Chelation of intracellular iron with the antifungal agent ciclopirox olamine induces cell death in leukemia and myeloma cells Blood, October 1, 2009; 114(14): 3064 - 3073. [Abstract] [Full Text] [PDF]

				R. E. Millikan, S. Wen, L. C. Pagliaro, M. A. Brown, B. Moomey, K.-A. Do, and C. J. Logothetis Phase III Trial of Androgen Ablation With or Without Three Cycles of Systemic Chemotherapy for Advanced Prostate Cancer J. Clin. Oncol., December 20, 2008; 26(36): 5936 - 5942. [Abstract] [Full Text] [PDF]

				P. F. Thall, C. Logothetis, L. C. Pagliaro, S. Wen, M. A. Brown, D. Williams, and R. E. Millikan Adaptive Therapy for Androgen-Independent Prostate Cancer: A Randomized Selection Trial of Four Regimens J Natl Cancer Inst, November 7, 2007; 99(21): 1613 - 1622. [Abstract] [Full Text] [PDF]

				A. Casati, V. S. Zimmermann, F. Benigni, M. T. S. Bertilaccio, M. Bellone, and A. Mondino The Immunogenicity of Dendritic Cell-Based Vaccines Is Not Hampered by Doxorubicin and Melphalan Administration J. Immunol., March 15, 2005; 174(6): 3317 - 3325. [Abstract] [Full Text] [PDF]

				A. Stangelberger, A. V. Schally, J. L. Varga, M. Zarandi, K. Szepeshazi, P. Armatis, and G. Halmos Inhibitory Effect of Antagonists of Bombesin and Growth Hormone-Releasing Hormone on Orthotopic and Intraosseous Growth and Invasiveness of PC-3 Human Prostate Cancer in Nude Mice Clin. Cancer Res., January 1, 2005; 11(1): 49 - 57. [Abstract] [Full Text] [PDF]