Journal of Clinical Oncology, Vol 15, 3394-3398, Copyright © 1997 by American Society of Clinical Oncology

ARTICLES

Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer

WM Stadler, T Kuzel, B Roth, D Raghavan and FA Dorr
University of Chicago, and Northwestern University Medical School, Chicago, IL 60637, USA. wmstadle@mcis.bsd.uchicago.edu

PURPOSE: To determine the activity of single-agent gemcitabine in previously untreated patients with metastatic transitional cell cancer. METHODS: Forty patients with measurable disease and a Karnofsky performance status > or = 60% were enrolled at five institutions between March 1994 and October 1995. Treatment consisted of gemcitabine (1,200 mg/m2) administered weekly times three on a 4-week cycle. One patient was ineligible for response evaluation because pathology review showed a metastatic melanoma. Responses were confirmed by all investigators and an independent radiologist and were maintained for at least 4 weeks. RESULTS: There were four complete and seven partial responses, for an overall response rate of 28%. Responses were seen at all sites, including liver. Median progression-free and overall survival times were 20 and 54 weeks, respectively. Toxicity was mild, with only two grade 4 toxicities. Twenty-five percent of patients experienced grade 3 neutropenia or thrombocytopenia that was rapidly reversible. CONCLUSION: Gemcitabine exhibits significant activity in metastatic transitional cell cancer with minimal toxicity, but survival remains short. Trials of gemcitabine in combination with other active agents are thus suggested.
CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				R. Addeo, M. Caraglia, S. Bellini, A. Abbruzzese, B. Vincenzi, L. Montella, A. Miragliuolo, R. Guarrasi, M. Lanna, G. Cennamo, et al. Randomized Phase III Trial on Gemcitabine Versus Mytomicin in Recurrent Superficial Bladder Cancer: Evaluation of Efficacy and Tolerance J. Clin. Oncol., February 1, 2010; 28(4): 543 - 548. [Abstract] [Full Text] [PDF]

				M. De Santis, J. Bellmunt, G. Mead, J. M. Kerst, M. Leahy, P. Maroto, I. Skoneczna, S. Marreaud, R. de Wit, and R. Sylvester Randomized Phase II/III Trial Assessing Gemcitabine/ Carboplatin and Methotrexate/Carboplatin/Vinblastine in Patients With Advanced Urothelial Cancer "Unfit" for Cisplatin-Based Chemotherapy: Phase II--Results of EORTC Study 30986 J. Clin. Oncol., November 20, 2009; 27(33): 5634 - 5639. [Abstract] [Full Text] [PDF]

				H von der Maase, J Lehmann, G Gravis, H Joensuu, P. Geertsen, J Gough, G Chen, and M Kania A phase II trial of pemetrexed plus gemcitabine in locally advanced and/or metastatic transitional cell carcinoma of the urothelium Ann. Onc., October 1, 2006; 17(10): 1533 - 1538. [Abstract] [Full Text] [PDF]

				G. Dalbagni, P. Russo, B. Bochner, L. Ben-Porat, J. Sheinfeld, P. Sogani, M. S. Donat, H. W. Herr, and D. Bajorin Phase II Trial of Intravesical Gemcitabine in Bacille Calmette-Guerin-Refractory Transitional Cell Carcinoma of the Bladder J. Clin. Oncol., June 20, 2006; 24(18): 2729 - 2734. [Abstract] [Full Text] [PDF]

				C. Theodore, F. Bidault, N. Bouvet-Forteau, M. Abdelatif, K. Fizazi, M. di Palma, P. Wibault, R. de Crevoisier, and A. Laplanche A phase II monocentric study of oxaliplatin in combination with gemcitabine (GEMOX) in patients with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract Ann. Onc., June 1, 2006; 17(6): 990 - 994. [Abstract] [Full Text] [PDF]

				C. P. Lee, M. J.A. de Jonge, A. E. O'Donnell, K. L. Schothorst, J. Hanwell, J. B. Chick, R. A. Brooimans, L. M. Adams, D. W. Drolet, J. S. de Bono, et al. A Phase I Study of a New Nucleoside Analogue, OSI-7836, Using Two Administration Schedules in Patients with Advanced Solid Malignancies. Clin. Cancer Res., May 1, 2006; 12(9): 2841 - 2848. [Abstract] [Full Text] [PDF]

				A. Bamias, I. Tiliakos, M.-D. Karali, and M. A. Dimopoulos Systemic chemotherapy in inoperable or metastatic bladder cancer Ann. Onc., April 1, 2006; 17(4): 553 - 561. [Abstract] [Full Text] [PDF]

				J. Li, B. Juliar, C. Yiannoutsos, R. Ansari, E. Fox, M. J. Fisch, L. H. Einhorn, and C. J. Sweeney Weekly Paclitaxel and Gemcitabine in Advanced Transitional-Cell Carcinoma of the Urothelium: A Phase II Hoosier Oncology Group Study J. Clin. Oncol., February 20, 2005; 23(6): 1185 - 1191. [Abstract] [Full Text] [PDF]

				G. Di Lorenzo, R. Autorino, A. Giordano, M. Giuliano, M. D'Armiento, A. R. Bianco, and S. De Placido FOLFOX-4 in Pre-treated Patients with Advanced Transitional Cell Carcinoma of the Bladder Jpn. J. Clin. Oncol., December 1, 2004; 34(12): 747 - 750. [Abstract] [Full Text] [PDF]

				E. Kent, H. Sandler, J. Montie, C. Lee, J. Herman, P. Esper, J. Fardig, and D. C. Smith Combined-Modality Therapy With Gemcitabine and Radiotherapy As a Bladder Preservation Strategy: Results of a Phase I Trial J. Clin. Oncol., July 1, 2004; 22(13): 2540 - 2545. [Abstract] [Full Text] [PDF]

				P. J. Mansky, J. Grem, D. B. Wallerstedt, B. P. Monahan, and M. R. Blackman Mistletoe and Gemcitabine in Patients with Advanced Cancer: A Model for the Phase I Study of Botanicals and Botanical-Drug Interactions in Cancer Therapy Integr Cancer Ther, December 1, 2003; 2(4): 345 - 352. [Abstract] [PDF]

				D. A. Rizzieri, V. K. Ibom, J. O. Moore, C. M. DeCastro, G. L. Rosner, D. J. Adams, T. Foster, N. Payne, M. Thompson, J. J. Vredenburgh, et al. Phase I Evaluation of Prolonged-infusion Gemcitabine with Fludarabine for Relapsed or Refractory Acute Myelogenous Leukemia Clin. Cancer Res., February 1, 2003; 9(2): 663 - 668. [Abstract] [Full Text] [PDF]

				G. Dalbagni, P. Russo, J. Sheinfeld, M. Mazumdar, W. Tong, F. Rabbani, M. S. Donat, H. W. Herr, P. Sogani, D. dePalma, et al. Phase I Trial of Intravesical Gemcitabine in Bacillus Calmette-Guerin-Refractory Transitional-Cell Carcinoma of the Bladder J. Clin. Oncol., August 1, 2002; 20(15): 3193 - 3198. [Abstract] [Full Text] [PDF]

				M. J. Egorin, E. G. Zuhowski, C. M. McCully, S. M. Blaney, J. Z. Kerr, S. L. Berg, and F. M. Balis Pharmacokinetics of Intrathecal Gemcitabine in Nonhuman Primates Clin. Cancer Res., July 1, 2002; 8(7): 2437 - 2442. [Abstract] [Full Text] [PDF]

				D. Pectasides, J. Glotsos, N. Bountouroglou, A. Kouloubinis, N. Mitakidis, N. Karvounis, N. Ziras, and A. Athanassiou Weekly chemotherapy with docetaxel, gemcitabine and cisplatin in advanced transitional cell urothelial cancer: a phase II trial Ann. Onc., February 20, 2002; 13(2): 243 - 250. [Abstract] [Full Text] [PDF]

				A. A. Meluch, F. A. Greco, H. A. Burris III, T. O'Rourke, G. Ortega, R. G. Steis, L. H. Morrissey, V. Johnson, and J. D. Hainsworth Paclitaxel and Gemcitabine Chemotherapy for Advanced Transitional-Cell Carcinoma of the Urothelial Tract: A Phase II Trial of the Minnie Pearl Cancer Research Network J. Clin. Oncol., June 15, 2001; 19(12): 3018 - 3024. [Abstract] [Full Text] [PDF]

				M. Hussain, U. Vaishampayan, W. Du, B. Redman, and D. C. Smith Combination Paclitaxel, Carboplatin, and Gemcitabine Is an Active Treatment for Advanced Urothelial Cancer J. Clin. Oncol., May 1, 2001; 19(9): 2527 - 2533. [Abstract] [Full Text] [PDF]

				J. Bellmunt, V. Guillem, L. Paz-Ares, J. L. Gonzalez-Larriba, J. Carles, E. Batiste-Alentorn, A. Saenz, M. Lopez-Brea, A. Font, M. Nogue, et al. Phase I-II Study of Paclitaxel, Cisplatin, and Gemcitabine in Advanced Transitional-Cell Carcinoma of the Urothelium J. Clin. Oncol., September 18, 2000; 18(18): 3247 - 3255. [Abstract] [Full Text] [PDF]

				H. von der Maase, S.W. Hansen, J.T. Roberts, L. Dogliotti, T. Oliver, M.J. Moore, I. Bodrogi, P. Albers, A. Knuth, C.M. Lippert, et al. Gemcitabine and Cisplatin Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Advanced or Metastatic Bladder Cancer: Results of a Large, Randomized, Multinational, Multicenter, Phase III Study J. Clin. Oncol., September 17, 2000; 18(17): 3068 - 3077. [Abstract] [Full Text] [PDF]

				A. P. Venook, M. J. Egorin, G. L. Rosner, D. Hollis, S. Mani, M. Hawkins, J. Byrd, R. Hohl, D. Budman, N. J. Meropol, et al. Phase I and Pharmacokinetic Trial of Gemcitabine in Patients With Hepatic or Renal Dysfunction: Cancer and Leukemia Group B 9565 J. Clin. Oncol., July 14, 2000; 18(14): 2780 - 2787. [Abstract] [Full Text] [PDF]

				E. J. Small, D. Lew, B. G. Redman, D. P. Petrylak, N. Hammond, H. M. Gross, J. A. Eastham, and E. D. Crawford Southwest Oncology Group Study of Paclitaxel and Carboplatin for Advanced Transitional-Cell Carcinoma: The Importance of Survival as a Clinical Trial End Point J. Clin. Oncol., July 1, 2000; 18(13): 2537 - 2544. [Abstract] [Full Text] [PDF]

				D. Kaufman, D. Raghavan, M. Carducci, E. G. Levine, B. Murphy, J. Aisner, T. Kuzel, S. Nicol, W. Oh, and W. Stadler Phase II Trial of Gemcitabine Plus Cisplatin in Patients With Metastatic Urothelial Cancer J. Clin. Oncol., May 9, 2000; 18(9): 1921 - 1927. [Abstract] [Full Text] [PDF]

				R. Dreicer, J. Manola, B. J. Roth, M. B. Cohen, A. K. Hatfield, and G. Wilding Phase II Study of Cisplatin and Paclitaxel in Advanced Carcinoma of the Urothelium: An Eastern Cooperative Oncology Group Study J. Clin. Oncol., March 1, 2000; 18(5): 1058 - 1058. [Abstract] [Full Text] [PDF]

				P. M. Dodd, J. A. McCaffrey, S. Hilton, M. Mazumdar, H. Herr, W. K. Kelly, E. Icasiano, M. G. Boyle, and D. F. Bajorin Phase I Evaluation of Sequential Doxorubicin Gemcitabine Then Ifosfamide Paclitaxel Cisplatin for Patients With Unresectable or Metastatic Transitional-Cell Carcinoma of the Urothelial Tract J. Clin. Oncol., February 14, 2000; 18(4): 840 - 840. [Abstract] [Full Text] [PDF]

				J. E. Groopman and L. M. Itri Chemotherapy-Induced Anemia in Adults: Incidence and Treatment J Natl Cancer Inst, October 6, 1999; 91(19): 1616 - 1634. [Abstract] [Full Text] [PDF]

				D. F. Bajorin, P. M. Dodd, M. Mazumdar, M. Fazzari, J. A. McCaffrey, H. I. Scher, H. Herr, G. Higgins, and M. G. Boyle Long-Term Survival in Metastatic Transitional-Cell Carcinoma and Prognostic Factors Predicting Outcome of Therapy J. Clin. Oncol., October 1, 1999; 17(10): 3173 - 3181. [Abstract] [Full Text] [PDF]

				P. J. Cozzi, D. F. Bajorin, W. Tong, H. Nguyen, J. Scott, W. D. W. Heston, and G. Dalbagni Toxicology and Pharmacokinetics of Intravesical Gemcitabine: A Preclinical Study in Dogs Clin. Cancer Res., September 1, 1999; 5(9): 2629 - 2637. [Abstract] [Full Text] [PDF]

				C. Bokemeyer, A. Gerl, P. Schoffski, A. Harstrick, N. Niederle, J. Beyer, J. Casper, H.J. Schmoll, and L. Kanz Gemcitabine in Patients With Relapsed or Cisplatin-Refractory Testicular Cancer J. Clin. Oncol., February 1, 1999; 17(2): 512 - 512. [Abstract] [Full Text] [PDF]