Investigational New Drugs

, Volume 10, Issue 4, pp 323–325 | Cite as

Phase II study of gemcitabine in advanced colorectal adenocarcinoma

  • Dennis F. MooreJr.
  • Richard Pazdur
  • Karen Daugherty
  • Peter Tarassoff
  • James L. Abbruzzese
Phase II Clinical Trials


A phase II trial of gemcitabine (difluorodeoxycytidine) was conducted in 14 patients with advanced colorectal adenocarcinoma. Gemcitabine was administered intravenously over 30 minutes at weekly intervals for 3 consecutive weeks each month. The starting dose was 800 mg/m2, with dose escalation as tolerated. No complete or partial response were observed. Ten patients experienced progressive disease while on therapy. Toxic effects were primarily hematologic in nature. Grade 3 toxicities included leukopenia (one patient at 1000 mg/m2), granulocytopenia (two patients at 800 mg/m2), anemia (two patients at 800 mg/m2), and myalgia (one patient at 800 mg/m2). No grade 4 toxic effects or treatment-associated deaths were observed. Gemcitabine, at the doses and schedule used in this study, did not demonstrate activity against advanced colorectal adenocarcinoma.

Key words

difluorodeoxycytidine gemcitabine colorectal adenocarcinoma carcinoma 


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Copyright information

© Kluwer Academic Publishers 1992

Authors and Affiliations

  • Dennis F. MooreJr.
    • 1
  • Richard Pazdur
    • 1
  • Karen Daugherty
    • 1
  • Peter Tarassoff
    • 1
  • James L. Abbruzzese
    • 1
  1. 1.Section of Gastrointestinal OncologyUniversity of Texas, M.D. Anderson Cancer CenterHoustonUSA

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