A phase II study of gemcitabine and capecitabine in metastatic renal cancer

A report of Cancer and Leukemia Group B protocol 90008

Authors

  • Walter M. Stadler MD,

    Corresponding author
    1. Section of Hematology/Oncology, Department of Medicine, University of Chicago Medical Center, Chicago, Illinois
    • Section of Hematology/Oncology, Department of Medicine, University of Chicago, 5841 South Maryland Avenue, MC-2115, Chicago, IL 60637
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    • Fax: (773) 702-3163

  • Susan Halabi PhD,

    1. Cancer and Leukemia Group B Statistical Center, Durham, North Carolina
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  • Brian Rini MD,

    1. Department of Medicine, University of California at San Francisco, San Francisco, California
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  • Marc S. Ernstoff MD,

    1. Department of Medicine, Dartmouth Medical School-Norris Cotton Cancer Center, Lebanon, New Hampshire
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  • Enrique Davila MD,

    1. Mount Sinai Medical Center, Miami, Florida
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  • Joel Picus MD,

    1. Department of Medicine, Washington University School of Medicine, St. Louis, Missouri
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  • Robert Barrier MS,

    1. Cancer and Leukemia Group B Statistical Center, Durham, North Carolina
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  • Eric J. Small MD,

    1. Department of Medicine, University of California at San Francisco, San Francisco, California
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  • for Cancer and Leukemia Group B

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    • The following institutions participated in this study: CALGB Statistical Center, Durham, NC (Stephen George, PhD; supported by CA33601); Cancer Centers of the Carolinas, Greenville, SC (Jeffrey K. Giguere, MD; supported by CA29165); Christiana Care Health Services, Inc. Community Clinical Oncology Program (CCOP), Wilmington, DE (Stephen Grubbs, MD; supported by CA45418); Dartmouth Medical School-Norris Cotton Cancer Center, Lebanon, NH (Marc S. Ernstoff, MD; supported by CA04326); Georgetown University Medical Center, Washington, DC (Edward Gelmann, MD; supported by CA77597); Grand Rapids Clinical Oncology Program, Grand Rapids, MI (Kathleen J. Yost, MD); Kansas City CCOP, Kansas City, MO (Jorge C. Paradelo, MD); Mount Sinai Medical Center, Miami, FL (Rogerio Lilenbaum, MD; supported by CA45564); Northern Indiana Cancer Research Consortium CCOP, South Bend, IN (Rafat Ansari, MD; supported by CA86726); Rhode Island Hospital, Providence, RI (William Sikov, MD; supported by CA08025); Roswell Park Cancer Institute, Buffalo, NY (Ellis Levine, MD; supported by CA02599); Southeast Cancer Control Consortium Inc. CCOP, Goldsboro, NC (James N. Atkins, MD; supported by CA45808); State University of New York Upstate Medical University, Syracuse, NY (Stephen L. Graziano, MD; supported by CA21060); Syracuse Hematology-Oncology Association CCOP, Syracuse, NY (Jeffrey Kirshner, MD; supported by CA45389); University of California at San Diego, San Diego, CA (Stephen L. Seagren, MD; supported by CA11789); University of Chicago Medical Center, Chicago, IL (Gini Fleming, MD; supported by CA41287); University of Iowa, Iowa City, IA (Gerald Clamon, MD; supported by CA47642); University of Missouri/Ellis Fischel Cancer Center, Columbia, MO (Michael C. Perry, MD; supported by CA12046); University of Nebraska Medical Center, Omaha, NE (Anne Kessinger, MD; supported by CA77298); University of North Carolina at Chapel Hill, Chapel Hill, NC (Thomas C. Shea, MD; supported by CA47559); and Washington University School of Medicine, St. Louis, MO (Nancy Bartlett, MD; supported by CA77440).


  • The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.

  • Presented in part at the Annual Meeting of the American Society of Clinical Oncology, New Orleans, Louisana, 2004.

Abstract

BACKGROUND

The objective of this study was to verify previous reports of activity with gemcitabine plus a fluoropyrimidine in patients with metastatic renal cell cancer in a multiinstitutional setting.

METHODS

Eligibility included a Zubrod performance status from 0 to 2, no prior gemcitabine or fluoropyrimidine therapy, and normal organ function. Patients received gemcitabine at a dose of 1000 mg/m2 on Days 1, 8, and 15 and capecitabine at a dose of 830 mg/m2 twice daily on Days 1 through 21 on a 28-day cycle with specified dose reductions for baseline renal insufficiency. The primary endpoint was the response rate, which was assessed every 8 weeks. The statistical plan tested the hypothesis that the response rate was 5% versus an alternative of 15%.

RESULTS

Sixty patients were enrolled, and 4 of those patients never started treatment. Of the 56 evaluable patients, 79% of patients underwent prior nephrectomy, 75% of patients received prior systemic therapy, and 75% of patients had clear cell histology. Risk stratification revealed that 34%, 43%, and 16% of patients were in Risk Groups 1, 2, and 3, respectively. Toxicity (graded according to the National Cancer Institute's Common Toxicity Criteria [version 2.0]) included Grade 3 or 4 neutropenia in 45% of patients, Grade 2 or greater fatigue in 32% of patients, Grade 2 or greater nausea in 29% of patients, Grade 2 or greater hand-foot reaction in 39% of patients, and Grade 2 or greater diarrhea in 22% of patients. Six patients responded (11%; 95% confidence interval, 4–22%), and the overall median survival was 14.5 months.

CONCLUSIONS

Gemcitabine plus capecitabine had modest activity in patients with metastatic renal cancer, although the degree of activity and its associated toxicity would not support further evaluation in a Phase III trial of unselected patients. More focused investigations to identify patients most likely to benefit or to enhance activity with additional agents would be reasonable. Cancer 2006. © 2006 American Cancer Society.

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