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A Phase II Pilot Study of KW-2189 in Patients with Advanced Renal Cell Carcinoma

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Abstract

Background: KW-2189 is a semi-synthetic, water-soluble analog of duocarmycin B2, a new class of potent antitumor antibiotics produced by streptomyces, with improved in vitro antitumor potency. Patients and methods: Forty patients with pathologically confirmed metastatic renal cell carcinoma were treated in this multicenter, open-label phase II trial. All patients received 0.4mg/m2 KW-2189 as an IV infusion for Cycle 1. Cycles were repeated every 5 to 6 weeks with escalations to 0.5 mg/m2 in the absence of significant toxicity or disease progression. Results:No patient had an objective response. The most common drug-related toxicity was hematological-delayed neutropenia and thrombocytopenia, with recovery by week 6. Non-hematologic toxicity consisted of mild to moderate fatigue, nausea and vomiting, and anorexia that was generally manageable. Conclusions: KW-2189 in this dose and schedule has a predictable safety profile of reversible myelosuppression. No activity in metastatic renal cell carcinoma was demonstrated.

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Authors and Affiliations

  1. UCSF Comprehensive Cancer Center, University of California, San Francisco, CA

    Eric J. Small, Robert Figlin, Daniel Petrylak, David J. Vaughn, Oliver Sartor, Ivan Horak, Rosemarie Pincus, Alton Kremer & Chris Bowden

  2. UCLA/Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA

    Eric J. Small, Robert Figlin, Daniel Petrylak, David J. Vaughn, Oliver Sartor, Ivan Horak, Rosemarie Pincus, Alton Kremer & Chris Bowden

  3. Columbia Presbyterian Medical Center, New York, NY

    Eric J. Small, Robert Figlin, Daniel Petrylak, David J. Vaughn, Oliver Sartor, Ivan Horak, Rosemarie Pincus, Alton Kremer, Chris Bowden & Chris Bowden

  4. Hospital of the University of Pennsylvania, Philadelphia, PA

    Eric J. Small, Robert Figlin, Daniel Petrylak, David J. Vaughn, Oliver Sartor, Ivan Horak, Rosemarie Pincus & Alton Kremer

  5. LSU Medical Center, Shreveport, LA

    Eric J. Small, Robert Figlin, Daniel Petrylak, David J. Vaughn, Oliver Sartor, Ivan Horak, Rosemarie Pincus, Alton Kremer & Chris Bowden

  6. Oncology Clinical Research and Development, Jansses Research Foundation, Titusville, NJ, USA

    Eric J. Small, Robert Figlin, Daniel Petrylak, David J. Vaughn, Oliver Sartor, Ivan Horak, Rosemarie Pincus, Alton Kremer & Chris Bowden

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  1. Eric J. Small
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  2. Robert Figlin
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  4. David J. Vaughn
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  8. Alton Kremer
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  9. Chris Bowden
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Small, E.J., Figlin, R., Petrylak, D. et al. A Phase II Pilot Study of KW-2189 in Patients with Advanced Renal Cell Carcinoma. Invest New Drugs 18, 193–198 (2000). https://doi.org/10.1023/A:1006386115312

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  • DOI: https://doi.org/10.1023/A:1006386115312

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