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Investigational New Drugs

, Volume 24, Issue 6, pp 515–520 | Cite as

A Phase II trial of epothilone B analogue BMS-247550 (NSC #710428) ixabepilone, in patients with advanced pancreas cancer: A Southwest Oncology Group study

  • Robert P. WhiteheadEmail author
  • Sheryl McCoy
  • Saul E. Rivkin
  • Howard M. Gross
  • Marcel E. Conrad
  • Gary C. Doolittle
  • Robert A. Wolff
  • J. Wendall Goodwin
  • Shaker R. Dakhil
  • James L. Abbruzzese
Phase II Studies

Summary

Purpose: The purpose of this Phase II multi-institutional study was to define the efficacy and toxicity of ixabepilone in patients with advance pancreatic adenocarcinoma.

Patients and methods: Patients were required to have pancreatic adenocarcinoma and metastatic or recurrent disease that was not amenable to curative resection. Performance status was 0-1, and patients could not have had prior chemotherapy, or chemoradiation therapy for their advanced disease although prior local palliative radiation was allowed. Ixabepilone was administered iv as a 3 hour infusion every 21 days. Initially, the dose was 50 mg/m2 but this was lowered to 40 mg/m2 shortly after the trial opened because of concerns about neurotoxicity.

Results: Sixty-two patients were registered however 2 were ineligible because they did not have recurrent or metastatic disease. For the 60 eligible patients, 22 had performance status of 0 and 38 performance status of 1. The estimated 6-month survival was 60% (95% CI 48%–72%) with a median survival of 7.2 months and an estimated time to treatment failure of 2.3 months. Out of 56 patients with measurable disease there were 5 confirmed partial responses for a confirmed response probability of 9% (95% CI 3%–20%) and 7 unconfirmed partial responses for an overall response probability of 21% (95% CI 12%–34%). Common toxicities were neutropenia/granulocytopenia, nausea and vomiting and neuropathy. There was one death, cause not determined but judged “possibly” related to treatment.

Conclusion: Ixabepilone shows encouraging activity in patients with advanced pancreatic cancer and should be investigated further in this disease.

Keywords

Phase II Epothilone B analogue Ixabepilone Pancreas cancer Southwest Oncology Group 

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Copyright information

© Springer Science + Business Media, LLC 2006

Authors and Affiliations

  • Robert P. Whitehead
    • 1
    Email author
  • Sheryl McCoy
    • 2
  • Saul E. Rivkin
    • 3
  • Howard M. Gross
    • 4
  • Marcel E. Conrad
    • 5
  • Gary C. Doolittle
    • 6
  • Robert A. Wolff
    • 7
  • J. Wendall Goodwin
    • 8
  • Shaker R. Dakhil
    • 9
  • James L. Abbruzzese
    • 7
  1. 1.Department of Internal MedicineUniversity of Texas Medical BranchGalveston
  2. 2.Southwest Oncology Group Statistical CenterSeattle
  3. 3.Puget Sound Oncology ConsortiumSeattle
  4. 4.Dayton Community Clinical Oncology ProgramDayton
  5. 5.Gulf Coast Minority Based Community Clinical Oncology ProgramMobile
  6. 6.University of Kansas Medical CenterKansas City
  7. 7.University of Texas MD Anderson Cancer CenterHouston
  8. 8.Ozarks Regional Community Clinical Oncology ProgramSpringfield
  9. 9.Wichita Community Clinical Oncology ProgramWichita

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