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 Jean 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 Citations (Scopus)

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 1998

Fingerprint

Leucovorin
Cimetidine
Renal Cell Carcinoma
Fluorouracil
Treatment Failure
Melanoma
Pyrimidines
Histamine H2 Receptors
interferon alfa-2a
Peptic Ulcer
Interferon-alpha
Mouth
Colorectal Neoplasms
Cell Line
Neoplasms

Keywords

  • Interferon
  • Renal cell cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A phase II study of high-dose cimetidine and the combination 5- fluorouracil, interferon alpha-2A, and leucovorin in advanced renal cell adenocarcinoma. / Creagan, Edward T.; Veeder, Michael H.; Suman, Vera Jean; Burch, Patrick A.; Maples, William J.; Schaefer, Paul L.; Pfeifle, Delano M.; Dalton, Robert J.; Hatfield, Alan K.; Poon, Michael A.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 21, No. 5, 10.1998, p. 475-478.

Research output: Contribution to journalArticle

Creagan, Edward T. ; Veeder, Michael H. ; Suman, Vera Jean ; Burch, Patrick A. ; Maples, William J. ; Schaefer, Paul L. ; Pfeifle, Delano M. ; Dalton, Robert J. ; Hatfield, Alan K. ; Poon, Michael A. / A phase II study of high-dose cimetidine and the combination 5- fluorouracil, interferon alpha-2A, and leucovorin in advanced renal cell adenocarcinoma. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 1998 ; Vol. 21, No. 5. pp. 475-478.
@article{f4d9d213f75b401ba5df2f076caee02f,
title = "A phase II study of high-dose cimetidine and the combination 5- fluorouracil, interferon alpha-2A, and leucovorin in advanced renal cell adenocarcinoma",
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.",
keywords = "Interferon, Renal cell cancer",
author = "Creagan, {Edward T.} and Veeder, {Michael H.} and Suman, {Vera Jean} and Burch, {Patrick A.} and Maples, {William J.} and Schaefer, {Paul L.} and Pfeifle, {Delano M.} and Dalton, {Robert J.} and Hatfield, {Alan K.} and Poon, {Michael A.}",
year = "1998",
month = "10",
doi = "10.1097/00000421-199810000-00011",
language = "English (US)",
volume = "21",
pages = "475--478",
journal = "American Journal of Clinical Oncology: Cancer Clinical Trials",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - A phase II study of high-dose cimetidine and the combination 5- fluorouracil, interferon alpha-2A, and leucovorin in advanced renal cell adenocarcinoma

AU - Creagan, Edward T.

AU - Veeder, Michael H.

AU - Suman, Vera Jean

AU - Burch, Patrick A.

AU - Maples, William J.

AU - Schaefer, Paul L.

AU - Pfeifle, Delano M.

AU - Dalton, Robert J.

AU - Hatfield, Alan K.

AU - Poon, Michael A.

PY - 1998/10

Y1 - 1998/10

N2 - 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.

AB - 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.

KW - Interferon

KW - Renal cell cancer

UR - http://www.scopus.com/inward/record.url?scp=0031756001&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031756001&partnerID=8YFLogxK

U2 - 10.1097/00000421-199810000-00011

DO - 10.1097/00000421-199810000-00011

M3 - Article

C2 - 9781603

AN - SCOPUS:0031756001

VL - 21

SP - 475

EP - 478

JO - American Journal of Clinical Oncology: Cancer Clinical Trials

JF - American Journal of Clinical Oncology: Cancer Clinical Trials

SN - 0277-3732

IS - 5

ER -