A phase II study of sequential methotrexate and 5-fluorouracil in metastatic pancreatic cancer

Masafumi Ikeda, Shuichi Okada, Hideki Ueno, Takuji Okusaka, Noriaki Tanaka, Hitoshi Kuriyama, Masayoshi Yoshimori

Research output: Contribution to journalArticlepeer-review

14 Scopus citations


Background/Aims: Sequential administration with methotrexate and 5-fluorouracil (sequential MTX/5-FU) has synergistic cytotoxic activity for several malignant diseases, but its activity in pancreatic cancer has not been fully evaluated. The aim of this study was to evaluate the antitumor activity and toxicity of sequential MTX/5-FU in metastatic pancreatic cancer. Methodology: All patients were required to have a pathologic diagnosis of pancreatic adenocarcinoma with measurable metastatic lesions, and no prior chemotherapy. Sequential MTX/5-FU was administered weekly as followed; MTX 100 mg/m2 intravenous bolus infusion was given, followed 3 h later by 5-fluorouracil 600 mg/m2 intravenous infusion over 30 min. Results: Thirty-one patients were enrolled and assessable for response and toxicity. There were no complete responses, 4 partial responses, 10 no change and 17 progressive disease. The response rate was 12.9% (95% confidence interval: 1.1-24.7%) and the duration of response was 7.1 months (range: 5.5-9.1 months). The median survival was 4.0 months. Chemotherapy was well tolerated, although grade 3-4 toxicities such as neutropenia and diarrhea were seen infrequently. Conclusions: The sequential MTX/5-FU had marginal antitumor activity with mild toxicity against metastatic pancreatic cancer.

Original languageEnglish
Pages (from-to)862-865
Number of pages4
Issue number33
StatePublished - 2000
Externally publishedYes


  • 5-Fluorouracil
  • Chemotherapy
  • Methotrexate
  • Pancreatic cancer


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