Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 4012
© 2004 American Society of Clinical Oncology

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Abstract

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

University of Texas Medical Branch, Galveston, TX; Southwest Oncology Group Statistical Center, Seattle, WA; Puget Sound Oncology Consortium, Seattle, WA; Dayton Community Clinical Oncology Program, Dayton, OH; Gulf Coast MBCCOP, Mobile, AL; University of Texas M. D. Anderson Cancer Ctr, Houston, TX

4012

Background: Advanced metastatic pancreatic cancer has a poor prognosis and short median survival with standard therapy. BMS-247550 is a semi-synthetic analog of the natural product epothilone B and has a mode of action similar to the taxanes but has activity in model systems resistant to paclitaxel. Methods: Patients were required to have a pathologic diagnosis of pancreatic adenocarcinoma with distant metastatic disease or recurrent disease that was not resectable. Prior surgery or palliative radiation therapy was allowed but patients could not have received prior chemotherapy or chemoradiation therapy. Zubrod performance status of 0 or 1, and adequate hematologic, hepatic and renal function was required. BMS-247550 was given at a dose of 40 mg/m² IV over 3 hours every 21 days. The study was designed with a primary endpoint of six-month survival, with a true six-month survival of 55% or greater judged important for further consideration of this regimen. Results: Sixty eligible patients were registered to the study with a median age of 60 years. Sixty percent were male. The estimated six-month survival is 59% (95% CI 46% to 71%) with a median survival of 6.9 months and a median time to treatment failure of 3.3 months. Of 54 patients with measurable disease, there were 4 confirmed partial responses, 7%, (95% CI 2%–18%), and 5 unconfirmed partial responses, 9%, for an overall response probability of 16% (95%CI 8%–29%). The most common grade 3 and 4 toxicities were neutropenia, leukopenia, nausea, vomiting, neuropathy and fatigue. There was one death, cause not determined, possibly related to treatment. Conclusions: The epothilone B analogue BMS-247550 shows activity in patients with metastatic or recurrent pancreatic cancer.

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Abstract presentation from the 2004 ASCO Annual Meeting