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01-02-2010 | PHASE II STUDIES

A phase II trial of Triapine® (NSC# 663249) and gemcitabine as second line treatment of advanced non-small cell lung cancer: Eastern Cooperative Oncology Group Study 1503

Authors: Anne M. Traynor, Ju-Whei Lee, Gerald K. Bayer, John M. Tate, Sachdev P. Thomas, Miroslaw Mazurczak, David L. Graham, Jill M. Kolesar, Joan H. Schiller

Published in: Investigational New Drugs | Issue 1/2010

Summary

Background: The objective of ECOG 1503 was to determine the response rate of this combination in the second-line treatment of advanced NSCLC. Methods: Triapine 105 mg/m² IV on days 1, 8, and 15, and gemcitabine 1,000 mg/m² on days 1, 8, and 15, of a 28 day cycle. Results: Eighteen patients enrolled. Three patients were not eligible due to protocol violations. No objective antitumor responses were seen. Three patients (20%) experienced stable disease (90% CI 5.7–44%). Median overall survival: 5.4 months (95% CI 4.2–11.6 months); median time to progression: 1.8 months (95% CI 1.7–3.5 months). Five patients developed acute infusion reactions to Triapine® related to elevated methemoglobinemia. Patients with MDR1 variant genotypes of C3435T experienced superior overall survival compared to non-variants (13.3 vs. 4.3 months, respectively, p = 0.023). Conclusion: This regimen did not demonstrate activity in relapsed NSCLC. Prolonged survival seen with MDR1 variant genotypes is hypothesis-generating.

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Title: A phase II trial of Triapine® (NSC# 663249) and gemcitabine as second line treatment of advanced non-small cell lung cancer: Eastern Cooperative Oncology Group Study 1503
Authors: Anne M. Traynor
Ju-Whei Lee
Gerald K. Bayer
John M. Tate
Sachdev P. Thomas
Miroslaw Mazurczak
David L. Graham
Jill M. Kolesar
Joan H. Schiller
Publication date: 01-02-2010
Publisher: Springer US
Published in: Investigational New Drugs / Issue 1/2010
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI: https://doi.org/10.1007/s10637-009-9230-z

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