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

Abstract

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/m(2) but this was lowered to 40 mg/m(2) 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.

• Authors: Robert P Whitehead, 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
• Journal: Investigational new drugs (Invest New Drugs) Vol. 24 Issue 6 Pg. 515-20 (Nov 2006) ISSN: 0167-6997 [Print] United States
• PMID: 16699973 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural)

Chemical References

• Epothilones
• Tubulin Modulators
• ixabepilone

Topics

• Adenocarcinoma (drug therapy, mortality, pathology, secondary)
• Adult
• Aged
• Aged, 80 and over
• Epothilones (adverse effects, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Pancreatic Neoplasms (drug therapy, mortality, pathology)
• Survival Analysis
• Treatment Outcome
• Tubulin Modulators (adverse effects, therapeutic use)