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Phase II study of Triapine® in patients with metastatic renal cell carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC IND.161)

  • PHASE II STUDIES
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Summary

Triapine® is a novel small molecule ribonucleotide reductase inhibitor that showed activity in renal cell carcinoma (RCC) cell lines. Evaluating new agents with novel mechanisms remains of interest for patients with incurable RCC. This was a single-arm, multicentre phase II trial where Triapine was given at a schedule of 96 mg/m2 2-h infusion daily × 4 repeated every 2 weeks in patients with recurrent RCC. A median of four cycles of Triapine was administered to 19 eligible patients. One response was seen (7%.) Median time to progression was 3.6 months. Common adverse events (AEs) were grade 1–2, with fatigue in 74%, nausea in 68% and vomiting in 58%. However grade 3/4 neutropenia was seen in 79% and acute reactions of hypoxia, hypotension, methemoglobinemia were seen. Dose reductions/delays due to AEs were common with only 47% of patients receiving > 90% of planned dose intensity. The study closed, at the end of stage 1 as it did not meet the minimal efficacy criteria to proceed. Further evaluation of Triapine at this dose and schedule in patients with advanced kidney cancer is not recommended.

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Acknowledgments

This trial was supported by grants from the National Cancer Institute of Canada, the National Cancer Institute Division of Cancer Therapy Evaluation Program (CTEP) and by Vion Therapeutics. The authors thank the following investigators who in addition to the co-authors enrolled patients on this study: Drs K Belanger, K Chi, S Ernst, I Tannock, P Venner and R Wong.

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Authors and Affiliations

  1. Department of Medical Oncology, University Health Network-OCI/Princess Margaret Hospital, 610 University Avenue, Toronto, ON, M5G 2M9, Canada

    Jennifer J. Knox

  2. Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON, Canada

    Sebastien J. Hotte

  3. British Columbia Cancer Agency- Vancouver Cancer Centre, Vancouver, BC, Canada

    Christian Kollmannsberger

  4. London Health Sciences Centre, London, ON, Canada

    Eric Winquist

  5. NCIC Clinical Trials Group, Queen’s University, Kingston, ON, Canada

    Bryn Fisher & Elizabeth A. Eisenhauer

Authors
  1. Jennifer J. Knox
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  2. Sebastien J. Hotte
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  3. Christian Kollmannsberger
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  4. Eric Winquist
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  5. Bryn Fisher
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  6. Elizabeth A. Eisenhauer
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Correspondence to Jennifer J. Knox.

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Knox, J.J., Hotte, S.J., Kollmannsberger, C. et al. Phase II study of Triapine® in patients with metastatic renal cell carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC IND.161). Invest New Drugs 25, 471–477 (2007). https://doi.org/10.1007/s10637-007-9044-9

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  • DOI: https://doi.org/10.1007/s10637-007-9044-9

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