Original Article

You have full text access to this OnlineOpen article

A Phase I trial of fixed dose rate gemcitabine and capecitabine in metastatic renal cell carcinoma

  1. Brian I. Rini M.D.†,*,
  2. Vivian Weinberg Ph.D.,
  3. Eric J. Small M.D.

Article first published online: 20 DEC 2004

DOI: 10.1002/cncr.20795

Issue

Cancer

Cancer

Volume 103, Issue 3, pages 553–558, 1 February 2005

Additional Information

How to Cite

Rini, B. I., Weinberg, V. and Small, E. J. (2005), A Phase I trial of fixed dose rate gemcitabine and capecitabine in metastatic renal cell carcinoma. Cancer, 103: 553–558. doi: 10.1002/cncr.20795

Author Information

  1. Department of Hematology/Oncology, The University of California San Francisco Comprehensive Cancer Center, San Francisco, California

  1. †

    Fax: (415) 353-7779

*Department of Hematology/Oncology, University of California San Francisco Comprehensive Cancer Center, 1600 Divisadero, 3rd Floor, San Francisco, CA 94115

Publication History

  1. Issue published online: 20 JAN 2005
  2. Article first published online: 20 DEC 2004
  3. Manuscript Accepted: 7 OCT 2004
  4. Manuscript Revised: 4 OCT 2004
  5. Manuscript Received: 16 JUL 2004

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (82K)

REFERENCES

  • 1
    Bukowski RM. Cytokine therapy for metastatic renal cell carcinoma. Semin Urol Oncol. 2001; 19: 148–154.
  • 2
    Yagoda A, Abi-Rached B, Petrylak D. Chemotherapy for advanced renal-cell carcinoma: 1983-1993. Semin Oncol. 1995; 22: 42–60.
  • 3
    Yagoda A, Petrylak D, Thompson S. Cytotoxic chemotherapy for advanced renal cell carcinoma. Urol Clin North Am. 1993; 20: 303–321.
  • 4
    Kish JA, Wolf M, Crawford ED, et al. Evaluation of low dose continuous infusion 5-fluorouracil in patients with advanced and recurrent renal cell carcinoma. A Southwest Oncology Group Study. Cancer. 1994; 74: 916–919.
    Direct Link:
  • 5
    Mertens WC, Eisenhauer EA, Moore M, et al. Gemcitabine in advanced renal cell carcinoma. A phase II study of the National Cancer Institute of Canada Clinical Trials Group. Ann Oncol. 1993; 4: 331–332.
  • 6
    De Mulder PH, Weissbach L, Jakse G, Osieka R, Blatter J. Gemcitabine: a phase II study in patients with advanced renal cancer. Cancer Chemother Pharmacol. 1996; 37: 491–495.
  • 7
    Rini BI, Vogelzang NJ, Dumas MC, Wade JL 3rd, Taber DA, Stadler WM. 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.
  • 8
    Schilsky RL. Pharmacology and clinical status of capecitabine. Oncology (Huntingt). 2000; 14: 1297–1306; discussion 1309–1311.
  • 9
    Van Cutsem E, Findlay M, Osterwalder B, et al. Capecitabine, an oral fluoropyrimidine carbamate with substantial activity in advanced colorectal cancer: results of a randomized phase II study. J Clin Oncol. 2000; 18: 1337–1345.
  • 10
    Blum JL, Jones SE, Buzdar AU, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999; 17: 485–493.
  • 11
    Huang P, Chubb S, Hertel LW, Grindey GB, Plunkett W. Action of 2',2'-difluorodeoxycytidine on DNA synthesis. Cancer Res. 1991; 51: 6110–6117.
  • 12
    Heinemann V, Xu YZ, Chubb S, et al. Inhibition of ribonucleotide reduction in CCRF-CEM cells by 2',2'- difluorodeoxycytidine. Mol Pharmacol. 1990; 38: 567–572.
  • 13
    Ren Q, Kao V, Grem JL. Cytotoxicity and DNA fragmentation associated with sequential gemcitabine and 5-fluoro-2'-deoxyuridine in HT-29 colon cancer cells. Clin Cancer Res. 1998; 4: 2811–2818.
  • 14
    George CM, Vogelzang NJ, Rini BI, Geoffroy FJ, Kollipara P, Stadler WM. A phase II trial of weekly intravenous gemcitabine and cisplatin with continuous infusion fluorouracil in patients with metastatic renal cell carcinoma. Ann Oncol. 2002; 13: 116–120.
  • 15
    Desai AA, Vogelzang NJ, Rini BI, Ansari R, Krauss S, Stadler WM. A high rate of venous thromboembolism in a multi-institutional phase II trial of weekly intravenous gemcitabine with continuous infusion fluorouracil and daily thalidomide in patients with metastatic renal cell carcinoma. Cancer. 2002; 95: 1629–1636.
    Direct Link:
  • 16
    Ryan CW, Vogelzang NJ, Stadler WM. A phase II trial of intravenous gemcitabine and 5-fluorouracil with subcutaneous interleukin-2 and interferon-alpha in patients with metastatic renal cell carcinoma. Cancer. 2002; 94: 2602–2609.
    Direct Link:
  • 17
    Stadler WM, Huo D, George C, et al. Prognostic factors for survival with gemcitabine plus 5-fluorouracil based regimens for metastatic renal cancer. J Urol. 2003; 170(4 Pt. 1): 1141–1145.
  • 18
    Schilsky RL, Bertucci D, Vogelzang NJ, Kindler HL, Ratain MJ. Dose-escalating study of capecitabine plus gemcitabine combination therapy in patients with advanced cancer. J Clin Oncol. 2002; 20: 582–587.
  • 19
    Grunewald R, Kantarjian H, Keating MJ, Abbruzzese J, Tarassoff P, Plunkett W. Pharmacologically directed design of the dose rate and schedule of 2',2'-difluorodeoxycytidine (gemcitabine) administration in leukemia. Cancer Res. 1990; 50: 6823–6826.
  • 20
    Abbruzzese JL, Grunewald R, Weeks EA, et al. A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J Clin Oncol. 1991; 9: 491–498.
  • 21
    Tempero M, Plunkett W, Ruiz Van Haperen V, et al. Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol. 2003; 21: 3402–3408.
  • 22
    Therasse 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: 205–216.
  • 23
    Fyfe GA, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Long-term response data for 255 patients with metastatic renal cell carcinoma treated with high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1996; 14: 2410–2411.
  • 24
    Ceribelli A, Gridelli C, De Marinis F, et al. Prolonged gemcitabine infusion in advanced non-small cell lung carcinoma: a randomized phase II study of two different schedules in combination with cisplatin. Cancer. 2003; 98: 337–343.
    Direct Link:
  • 25
    Mani S, Vogelzang NJ, Bertucci D, Stadler WM, Schilsky RL, Ratain MJ. Phase I study to evaluate multiple regimens of intravenous 5- fluorouracil administered in combination with weekly gemcitabine in patients with advanced solid tumors: a potential broadly active regimen for advanced solid tumor malignancies. Cancer. 2001; 92: 1567–1576.
    Direct Link:
View Full Article (HTML) Get PDF (82K)