Investigational New Drugs

, Volume 6, Issue 1, pp 47–50 | Cite as

Phase II study of fludarabine phosphate in patients with advanced colorectal carcinoma

  • Jaffer A. Ajani
  • James L. Abbruzzese
  • Jack S. Faintuch
  • Roxann Blackburn
  • Bernard Levin
  • Bruce M. Boman
Article

Summary

For phase II studies in patients with solid tumors, the National Cancer Institute recommended that the starting dose of fludarabine phosphate be 20 mg/m2/day as a short intravenous infusion for 5 days every 21 days. Twenty-one patients with untreated, advanced, measurable colorectal carcinoma received fludarabine phosphate as a 30-minute infusion at a median dose of 25 mg/mVday (range 15–35 mg/m2day) for 5 consecutive days repeated every three weeks. Antitumor response was evaluated following two courses of therapy. No patient achieved complete or partial response. Minor regression of lung metastases occurred for less than 12 weeks in one patient. Therapy was generally well tolerated. Frequent toxicities included lymphopenia, mild nausea and vomiting, mucositis, and anorexia. One patient died of sepsis, bleeding, and progressive disease while she was severely myelosuppressed. Neurotoxicity was not observed in any patient. Fludarabine phosphate at this schedule and dose range is inactive against colorectal carcinoma.

Key words

colorectal carcinoma fludarabine phosphate 2-fluoro ara-AMP 

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Copyright information

© Martinus Nijhoff Publishers 1988

Authors and Affiliations

  • Jaffer A. Ajani
    • 1
  • James L. Abbruzzese
    • 1
  • Jack S. Faintuch
    • 1
  • Roxann Blackburn
    • 1
  • Bernard Levin
    • 1
  • Bruce M. Boman
    • 1
  1. 1.The Department of Medical Oncology, Division of MedicineThe University of Texas, M.D. Anderson Hospital and Tumor Institute at HoustonHoustonUSA

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