A phase I study of 5-fluorouracil, leucovorin, and celecoxib in patients with incurable colorectal cancer

Prostaglandins Other Lipid Mediat. 2005 Jan;75(1-4):169-72. doi: 10.1016/j.prostaglandins.2004.10.004.


A phase I study of fixed-dose 5-fluorouracil (FU) and leucovorin (LCV), with excalating doses of the selective cyclooxygenase-2 (COX-2) inhibitor celecoxib, was conducted in 16 patients with advanced colorectal adenocarcinoma. At doses typically used to treat arthritis patients (100-200 mg po BID), celecoxib did not increase toxicities expected from the chemotherapy alone. 5-FU and leucovorin did not affect COX-2 inhibition by celecoxib. Preliminary data suggest it is safe to combine celecoxib with standard chemotherapeutic agents, in treatment of patients with colorectal cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdominal Pain
  • Antineoplastic Combined Chemotherapy Protocols / toxicity*
  • Celecoxib
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / pathology
  • Cyclooxygenase Inhibitors / administration & dosage
  • Diarrhea
  • Drug Administration Schedule
  • Fluorouracil / administration & dosage
  • Humans
  • Leucovorin / administration & dosage
  • Pyrazoles / administration & dosage
  • Sulfonamides / administration & dosage


  • Cyclooxygenase Inhibitors
  • Pyrazoles
  • Sulfonamides
  • Celecoxib
  • Leucovorin
  • Fluorouracil