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Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium

  • PHASE II STUDIES
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Summary

Background Sorafenib, an inhibitor of B-raf, VEGFR2, and PDGFR-β, has activity against pancreatic cancer in preclinical models. In a phase I trial of gemcitabine plus sorafenib, 57% of pancreatic cancer patients achieved stable disease. Patients and methods We conducted a multi-center phase II trial of sorafenib plus gemcitabine in chemo-naïve patients with histologically-confirmed, advanced pancreatic cancer. Patients received sorafenib 400 mg twice daily and gemcitabine 1,000 mg/m2 on days 1, 8 and 15 of a 28 day cycle. Results Seventeen patients enrolled at 4 centers; 13 were evaluable for response. There were no objective responses; 18% had stable disease. Median overall survival was 4.0 months (95% CI: 3.4, 5.9); median progression-free survival was 3.2 months (95% CI: 1.6, 3.6). Grade 3/4 toxicities included thrombosis in 18% of patients, dehydration or hand-foot syndrome in 12%, and hypertension or gastrointestinal bleeding in 6%. Conclusion Gemcitabine plus sorafenib is inactive in advanced pancreatic cancer.

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Funding source

NCI Grant N01-CM-62201

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Authors and Affiliations

  1. Department of Medicine, Section of Hematology/Oncology, University of Chicago, 5841 South Maryland Avenue, MC 2115, Chicago, IL, 60637, USA

    Hedy Lee Kindler, James A. Wallace, Michael J. Hall, Walter M. Stadler & Everett E. Vokes

  2. Department of Health Studies, University of Chicago, Chicago, IL, USA

    Kristen Wroblewski

  3. North Shore University Health System, Evanston, IL, USA

    Gershon Locker

  4. Fort Wayne Medical Oncology, Ft. Wayne, IN, USA

    Sreenivasa Nattam

  5. Central Illinois Hematology/Oncology, Springfield, IL, USA

    Edem Agamah

Authors
  1. Hedy Lee Kindler
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  2. Kristen Wroblewski
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  3. James A. Wallace
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  4. Michael J. Hall
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  5. Gershon Locker
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  6. Sreenivasa Nattam
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  7. Edem Agamah
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  8. Walter M. Stadler
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  9. Everett E. Vokes
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Correspondence to Hedy Lee Kindler.

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Kindler, H.L., Wroblewski, K., Wallace, J.A. et al. Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium. Invest New Drugs 30, 382–386 (2012). https://doi.org/10.1007/s10637-010-9526-z

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  • DOI: https://doi.org/10.1007/s10637-010-9526-z

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