A phase II study of high-dose cimetidine and the combination 5- fluorouracil, interferon alpha-2A, and leucovorin in advanced renal cell adenocarcinoma

Edward T. Creagan, Michael H. Veeder, Vera J. Suman, Patrick A. Burch, William J. Maples, Paul L. Schaefer, Delano M. Pfeifle, Robert J. Dalton, Alan K. Hatfield, Michael A. Poon

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

Cimetidine is an H2-receptor antagonist used in the management of peptic ulcer disease and other hypersecretory gastrointestinal disorders. This agent has intriguing immunomodulatory characteristics. A phase II trial of cimetidine in 19 patients with advanced malignant melanoma yielded an objective response rate of 16%. Having demonstrated that cimetidine is active in malignant melanoma, the authors conducted a phase II trial of cimetidine, 800 mg twice daily by mouth, in patients with advanced renal cell cancer. Among the 31 eligible patients, only one (3.2%) achieved a regression. It was a partial regression lasting 93 days. Median time to treatment failure was 83 days. The combination of interferon alpha-2A (IFL-RA) and 5-fluorouracil (5- FU) has been shown to be synergistic against experimental cell lines in vitro. Citrovorum factor (CF) added to 5-FU has been shown to improve objective tumor response compared with single-agent 5-FU in patients with advanced colorectal cancer. Fluorinated pyrimidines have shown some activity against renal cell cancer. We conducted a phase II trial of the combination of CF at 20 mg/m2 intravenous push followed by 5-FU at 325 mg/m2 intravenously daily for 5 days every week with interferon alpha-2A 5 x 106 units/m2 subcutaneously on days 1, 3, 5 in patients with advanced renal cell cancer. Among the 31 eligible patientS, only two (6.5%) achieved a regression. Both were partial regressions. Median time to treatment failure was 84 days. Neither regimen is recommended for further testing in patients with advanced renal cell adenocarcinoma.

Original languageEnglish (US)
Pages (from-to)475-478
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume21
Issue number5
DOIs
StatePublished - Oct 1 1998

Keywords

  • Interferon
  • Renal cell cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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