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Investigational New Drugs

, Volume 30, Issue 1, pp 382–386 | Cite as

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

  • Hedy Lee Kindler
  • Kristen Wroblewski
  • James A. Wallace
  • Michael J. Hall
  • Gershon Locker
  • Sreenivasa Nattam
  • Edem Agamah
  • Walter M. Stadler
  • Everett E. Vokes
PHASE II STUDIES

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.

Keywords

Pancreatic cancer Phase II trial Gemcitabine Sorafenib 

Notes

Funding source

NCI Grant N01-CM-62201

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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Hedy Lee Kindler
    • 1
  • Kristen Wroblewski
    • 2
  • James A. Wallace
    • 1
  • Michael J. Hall
    • 1
  • Gershon Locker
    • 3
  • Sreenivasa Nattam
    • 4
  • Edem Agamah
    • 5
  • Walter M. Stadler
    • 1
  • Everett E. Vokes
    • 1
  1. 1.Department of Medicine, Section of Hematology/OncologyUniversity of ChicagoChicagoUSA
  2. 2.Department of Health StudiesUniversity of ChicagoChicagoUSA
  3. 3.North Shore University Health SystemEvanstonUSA
  4. 4.Fort Wayne Medical OncologyFt. WayneUSA
  5. 5.Central Illinois Hematology/OncologySpringfieldUSA

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