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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

  • PHASE II STUDIES
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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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Acknowledgments

The authors thank the patients who participated in this trial, as well as the investigators who enrolled patients, and the data managers, and the clinical and research nurses who brought this trial to completion. This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D., Chair) and supported in part by the University of Wisconsin Paul P. Carbone Comprehensive Cancer Center K12 CA087716 and 5 P30 CA014520-35, and by the Public Health Service Grants CA23318, CA66636, CA21115, CA21076, and from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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Authors and Affiliations

  1. University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, University of Wisconsin School of Medicine and Public Health, K6/568 CSC, #5669, 600 Highland Avenue, Madison, WI, 53792, USA

    Anne M. Traynor & Jill M. Kolesar

  2. Eastern Cooperative Oncology Group and the Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA

    Ju-Whei Lee

  3. Green Bay Oncology, Saint Vincent Hospital, Green Bay, WI, USA

    Gerald K. Bayer

  4. Roger Maris Cancer Center, Merit Care Hospital CCOP, Fargo, ND, USA

    John M. Tate

  5. Illinois Cancer Care, Peoria, IL, USA

    Sachdev P. Thomas

  6. Sanford Clinic Oncology, Sanford Hospital, Sioux Falls, SD, USA

    Miroslaw Mazurczak

  7. Carle Cancer Association, Urbana, IL, USA

    David L. Graham

  8. Division of Hematology and Oncology, Department of Internal Medicine, University of Texas at Southwestern Medical Center, Dallas, TX, USA

    Joan H. Schiller

Authors
  1. Anne M. Traynor
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  2. Ju-Whei Lee
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  3. Gerald K. Bayer
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  4. John M. Tate
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  5. Sachdev P. Thomas
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  6. Miroslaw Mazurczak
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  7. David L. Graham
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  8. Jill M. Kolesar
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  9. Joan H. Schiller
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Corresponding author

Correspondence to Anne M. Traynor.

Additional information

This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D., Chair) and supported in part by the University of Wisconsin Paul P. Carbone Comprehensive Cancer Center K12 CA087716 and 5 P30 CA014520-35, and by the Public Health Service Grants CA23318, CA66636, CA21115, CA21076, and from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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Traynor, A.M., Lee, JW., Bayer, G.K. et al. 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. Invest New Drugs 28, 91–97 (2010). https://doi.org/10.1007/s10637-009-9230-z

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  • DOI: https://doi.org/10.1007/s10637-009-9230-z

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