Urologic Oncology: Seminars and Original Investigations
Volume 24, Issue 6 , Pages 487-491 , November 2006

Phase II study of capecitabine single-agent therapy in patients with metastatic renal cell carcinoma

Presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31–June 3, 2003

Received 22 September 2005 ,Revised 16 March 2006 ,Accepted 17 March 2006.

References 

  1. Motzer RJ. Renal cell carcinoma: A priority malignancy for development and study of novel therapies. J Clin Oncol. 2003;21:1193–1194
  2. Rini BI. New approaches in advanced renal cell carcinoma. Urol Oncol. 2005;23:65–66
  3. Medical Research Council Renal Cancer Collaborators. Interferon-alpha and survival in metastatic renal carcinoma: Early results of a randomised controlled trial. Lancet. 1999;353:14–17
  4. Yang JC, Sherry RM, Steinberg SM, et al. Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol. 2003;21:3127–3132
  5. Motzer R, Murphy B, Mazumdar M, et al. Randomized Phase III trial of interferon alfa-2a versus interferon plus 13-cis-retinoic acid in patients with advanced renal cell carcinoma. Proc Am Soc Clin Oncol. 1999;18:330a;[Abstract 1271]
  6. Yagoda A, Abi-Rached B, Petrylak D. Chemotherapy for advanced renal-cell carcinoma: 1983–1993. Semin Oncol. 1995;22:42–60
  7. von Roemeling R, Rabatin JT, Fraley EE, et al. Progressive metastatic renal cell carcinoma controlled by continuous 5-fluoro-2-deoxyuridine infusion. J Urol. 1988;139:259–262
  8. Dexeus FH, Logothetis CJ, Sella A, et al. Circadian infusion of floxuridine in patients with metastatic renal cell carcinoma. J Urol. 1991;146:709–713
  9. Ellerhorst JA, Sella A, Amato RJ, et al. Phase II trial of 5-fluorouracil, interferon-alpha and continuous infusion interleukin-2 for patients with metastatic renal cell carcinoma. Cancer. 1997;80:2128–2132
  10. Negrier S, Caty A, Lesimple T, et al. Treatment of patients with metastatic renal carcinoma with a combination of subcutaneous interleukin-2 and interferon alfa with or without fluorouracil. J Clin Oncol. 2000;18:4009–4015
  11. Rini BI, Vogelzang NJ, Dumas MC, et al. Phase II trial of weekly intravenous gemcitabine with continuous infusion fluorouracil in patients with metastatic renal cell cancer. J Clin Oncol. 2000;18:2419–2426
  12. Atzpodien J, Kirchner H, Jonas U, et al. Interleukin-2- and interferon alfa-2a-based immunochemotherapy in advanced renal cell carcinoma: A Prospectively Randomized Trial of the German Cooperative Renal Carcinoma Chemoimmunotherapy Group (DGCIN). J Clin Oncol. 2004;22:1188–1194
  13. Ahlgren J, Lokich J, Auerbach M, et al. Protracted infusional 5FU: A well-tolerated regimen in metastatic renal carcinoma. Proc Am Soc Clin Oncol. 1993;12:244;[Abstract 763]
  14. Masuda F, Nakada J, Kondo I, et al. Adjuvant chemotherapy with vinblastine, Adriamycin, and UFT for renal-cell carcinoma. Cancer Chemother Pharmacol. 1992;30:477–479
  15. Atzpodien J, Kirchner H, Hanninen EL, et al. Interleukin-2 in combination with interferon-alpha and 5-fluorouracil for metastatic renal cell cancer. Eur J Cancer. 1993;29A(Suppl 5):S6–S8
  16. Ishikawa T, Utoh M, Sawada N, et al. Tumor selective delivery of 5-fluorouracil by capecitabine, a new oral fluoropyrimidine carbamate, in human cancer xenografts. Biochem Pharmacol. 1998;55:1091–1097
  17. Budman DR, Meropol NJ, Reigner B, et al. Preliminary studies of a novel oral fluoropyrimidine carbamate: Capecitabine. J Clin Oncol. 1998;16:1795–1802
  18. Mackean M, Planting A, Twelves C, et al. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol. 1998;16:2977–2985
  19. Gehan E. The determinator of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J Chronic Dis. 1961;13:346–353
  20. Grignon DJ, Ro JY, Ayala AG. Primary mucin-secreting adenocarcinoma of the kidney. Arch Pathol Lab Med. 1988;112:847–849
  21. Motzer RJ, Mazumdar M, Bacik J, et al. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999;17:2530–2540
  22. Wenzel C, Locker GJ, Schmidinger M, et al. Capecitabine in the treatment of metastatic renal cell carcinoma failing immunotherapy. Am J Kidney Dis. 2002;39:48–54
  23. Padrik P, Leppik K, Arak A. Combination therapy with capecitabine and interferon alfa-2A in patients with advanced renal cell carcinoma: A phase II study. Urol Oncol. 2004;22:387–392
  24. Waters JS, Moss C, Pyle L, et al. Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma. Br J Cancer. 2004;91:1763–1768
  25. Stadler WM, Halabi S, Ernstoff MS, et al. A phase II study of gemcitabine and capecitabine in patients with metastatic renal cell cancer: A report of Cancer and Leukemia Group B #90008. J Clin Oncol. 2004;22(Suppl 14):385s;[Abstract 4515]
  26. Copur MS, Ledakis P, Bolton M, et al. An adverse interaction between warfarin and capecitabine: A case report and review of the literature. Clin Colorectal Cancer. 2001;1:182–184
  27. Chang DZ, Olencki T, Budd GT, et al. Phase I trial of capecitabine in combination with interferon alpha in patients with metastatic renal cancer: toxicity and pharmacokinetics. Cancer Chemother Pharmacol. 2001;48:493–498
  28. Schilsky RL, Bertucci D, Vogelzang NJ, et al. Dose-escalating study of capecitabine plus gemcitabine combination therapy in patients with advanced cancer. J Clin Oncol. 2002;20:582–587
  29. Tannir N, Jonasch E, McMichael C, et al. A phase II trial of gemcitabine plus capecitabine in patients with advanced renal cell cancer previously treated with immunotherapy. J Clin Oncol. 2005;23(Suppl 16):402s;[Abstract 4598]
  30. Yang JC, Haworth L, Sherry RM, et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med. 2003;349:427–434
  31. Ratain M, Eisen T, Stadler W, et al. Final findings from a phase II, placebo-controlled, randomized discontinuation trial of sorafenib (BAY 43–9006) in patients with advanced renal cell carcinoma. J Clin Oncol. 2005;23(Suppl 16):388s;[Abstract 4544]
  32. Motzer RJ, Michaelson MD, Redman BG, et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006;24:16–24
  33. Miller KD, Chap LI, Holmes FA, et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005;23:792–799
  34. Siu LL, Awada A, Takimoto CH, et al. Phase I trial of sorafenib and gemcitabine in advanced solid tumors with an expanded cohort in advanced pancreatic cancer. Clin Cancer Res. 2006;12:144–151
  35. Kupsch P, Henning BF, Passarge K, et al. Results of a phase I trial of sorafenib (BAY 43–9006) in combination with oxaliplatin in patients with refractory solid tumors, including colorectal cancer. Clin Colorectal Cancer. 2005;5:188–196

☆ This work was supported by Roche Laboratories, Inc., Nutley, NJ, and NCI core grant No. CA16672.

PII: S1078-1439(06)00091-3

doi: 10.1016/j.urolonc.2006.03.004

Urologic Oncology: Seminars and Original Investigations
Volume 24, Issue 6 , Pages 487-491 , November 2006

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