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

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

Research output: Contribution to journalArticle

80 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)91-97
Number of pages7
JournalInvestigational New Drugs
Volume28
Issue number1
DOIs
StatePublished - Jan 2010

Keywords

  • ATP binding cassette transporter
  • Combination chemotherapy
  • Non-small cell lung cancer
  • Ribonucleotide reductase
  • Single nucleotide polymorphism

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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    Traynor, A. M., Lee, J. W., Bayer, G. K., Tate, J. M., Thomas, S. P., Mazurczak, M., Graham, D. L., Kolesar, J. M., & Schiller, J. H. (2010). 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. Investigational New Drugs, 28(1), 91-97. https://doi.org/10.1007/s10637-009-9230-z