A PHASE-I CLINICAL-TRIAL OF A PROTRACTED CONTINUOUS-INFUSION OF 5-FLUOROURACIL WITH ORAL FOLINIC ACID IN PATIENTS WITH UNRESECTABLE ADENOCARCINOMA OF THE COLON OR RECTUM

  • Authors:
    • DV JONES
    • KR DAUGHERTY
    • JL ABBRUZZESE
  • View Affiliations

  • Published online on: July 1, 1995     https://doi.org/10.3892/ijo.7.1.191
  • Pages: 191-194
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Abstract

Studies of the mechanism of action of 5-fluorouracil (5-FU) suggest that maximal inhibition of the target enzyme thymidylate synthase can be achieved with a protracted infusion of 5-FU and oral leucovorin. We report the results of a phase I study in which seven patients with advanced colorectal cancer were treated with a 30-day continuous infusion of 5-FU and a fixed 50 mg dose of oral folinic acid every 6 hours. The 5-FU dose started at 100 mg/m(2)/day with planned escalations of 50 mg/m(2)/day. The qualitative toxic effects observed included diarrhea, mucositis, and hand/foot syndrome. These toxic effects were manageable at 100 mg/m(2)/day, but became dose-limiting at 150 mg/m(2)/day with two of four patients unable to complete the planned 30-day infusion. No objective responses were observed, but minor activity was documented in two patients. We recommend a starting dose of 125 mg/m(2)/day for subsequent phase II trials of this regimen in patients with colorectal cancer.

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July 1995
Volume 7 Issue 1

Print ISSN: 1019-6439
Online ISSN:1791-2423

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Spandidos Publications style
JONES D, DAUGHERTY K and ABBRUZZESE J: A PHASE-I CLINICAL-TRIAL OF A PROTRACTED CONTINUOUS-INFUSION OF 5-FLUOROURACIL WITH ORAL FOLINIC ACID IN PATIENTS WITH UNRESECTABLE ADENOCARCINOMA OF THE COLON OR RECTUM. Int J Oncol 7: 191-194, 1995
APA
JONES, D., DAUGHERTY, K., & ABBRUZZESE, J. (1995). A PHASE-I CLINICAL-TRIAL OF A PROTRACTED CONTINUOUS-INFUSION OF 5-FLUOROURACIL WITH ORAL FOLINIC ACID IN PATIENTS WITH UNRESECTABLE ADENOCARCINOMA OF THE COLON OR RECTUM. International Journal of Oncology, 7, 191-194. https://doi.org/10.3892/ijo.7.1.191
MLA
JONES, D., DAUGHERTY, K., ABBRUZZESE, J."A PHASE-I CLINICAL-TRIAL OF A PROTRACTED CONTINUOUS-INFUSION OF 5-FLUOROURACIL WITH ORAL FOLINIC ACID IN PATIENTS WITH UNRESECTABLE ADENOCARCINOMA OF THE COLON OR RECTUM". International Journal of Oncology 7.1 (1995): 191-194.
Chicago
JONES, D., DAUGHERTY, K., ABBRUZZESE, J."A PHASE-I CLINICAL-TRIAL OF A PROTRACTED CONTINUOUS-INFUSION OF 5-FLUOROURACIL WITH ORAL FOLINIC ACID IN PATIENTS WITH UNRESECTABLE ADENOCARCINOMA OF THE COLON OR RECTUM". International Journal of Oncology 7, no. 1 (1995): 191-194. https://doi.org/10.3892/ijo.7.1.191