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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

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Keywords:

  • renal cell carcinoma;
  • gemcitabine;
  • capecitabine;
  • fixed dose rate

Abstract

BACKGROUND

Metastatic renal cell carcinoma (RCC) has modest response rates to chemotherapy with gemcitabine and 5-fluorouracil (5-FU). Fixed dose rate gemcitabine infusion leads to enhanced intracellular accumulation of drug and possible augmented clinical effect. To determine the toxicity of this combination therapy in metastatic RCC, a Phase I trial was conducted.

METHODS

Patients with metastatic RCC were enrolled in a Phase I dose escalation trial. Patients received fixed dose rate gemcitabine on Days 1, 8, and 15 in combination with capecitabine, an oral 5-FU analog, given on Days 1–21 of a 28-day cycle.

RESULTS

Nine patients were enrolled at one of two dose levels. The initial dose level produced dose-limiting toxicity (DLT), including prominent palmar-plantar erythrodysesthesia (hand-foot syndrome). A modified second dose level also resulted in DLT, precluding further study. No central nervous system (CNS) toxicity was observed in three patients with CNS metastases. Two patients demonstrated an objective partial response.

CONCLUSIONS

Fixed dose rate gemcitabine in combination with capecitabine produced unacceptable toxicity in patients with advanced RCC. Further development of this schedule in RCC cannot be recommended. Cancer 2005. © 2004 American Cancer Society.

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