Whitehead Robert P, McCoy Sheryl, Rivkin Saul E, Gross Howard M, Conrad Marcel E, Doolittle Gary C, Wolff Robert A, Goodwin J Wendall, Dakhil Shaker R, Abbruzzese James L
Department of Internal Medicine, University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555-0565, USA.
Invest New Drugs. 2006 Nov;24(6):515-20. doi: 10.1007/s10637-006-8440-x.
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 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.
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.
Ixabepilone shows encouraging activity in patients with advanced pancreatic cancer and should be investigated further in this disease.
