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Investigational New Drugs

, Volume 29, Issue 4, pp 694–699 | Cite as

A phase II study of isoflavones, erlotinib, and gemcitabine in advanced pancreatic cancer

  • Bassel Fuad El-RayesEmail author
  • Philip A. Philip
  • Fazlul H. Sarkar
  • Anthony F. Shields
  • Ann Marie Ferris
  • Kenneth Hess
  • Ahmad O. Kaseb
  • Milind M. Javle
  • Gauri R. Varadhachary
  • Robert A. Wolff
  • James L. Abbruzzese
PHASE II STUDIES

Summary

Background: The EGFR/Akt/NF-κB signalling pathway is frequently deregulated in pancreatic cancer and contributes to cell growth, metastasis and chemoresistance. An isoflavone, genistein, inactivates Akt and NF-κB and enhances the anti-tumor activity of erlotinib and gemcitabine in experimental systems of pancreas cancer. This phase II study was undertaken to determine the effects of adding isoflavone to a regimen of gemcitabine and erlotinib on survival in patients with advanced pancreatic cancer. Methods: Eligibility included previously untreated patients with advanced pancreatic adenocarcinoma. Patients received gemcitabine 1,000 mg/m2 on days 1, 8, and 15, and erlotinib 150 mg once daily P.O. on day 1 to day 28. Soy isoflavones (Novasoy®) were administered at a dose of 531 mg twice daily P.O. starting day -7 until the end of study participation. Results: Twenty patients with advanced pancreas cancer were enrolled (median age 57.9 years). Sixteen patients had stage IV disease. The median number of cycles was 2 per patient. The median survival time was 5.2 months (95% CI, 4.6—N/A months). The probability of survival at 6 months was 50% (95% CI, 32–78%). Conclusions: The addition of soy isoflavones to gemcitabine and erlotinib did not appear to increase the survival of patients with advanced pancreatic cancer.

Keywords

Pancreatic cancer Genistein Isoflavone Erlotinib Gemcitabine 

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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Bassel Fuad El-Rayes
    • 1
    • 3
    Email author
  • Philip A. Philip
    • 1
  • Fazlul H. Sarkar
    • 1
  • Anthony F. Shields
    • 1
  • Ann Marie Ferris
    • 1
  • Kenneth Hess
    • 2
  • Ahmad O. Kaseb
    • 2
  • Milind M. Javle
    • 2
  • Gauri R. Varadhachary
    • 2
  • Robert A. Wolff
    • 2
  • James L. Abbruzzese
    • 2
  1. 1.Karmanos Cancer InstituteWayne State UniversityDetroitUSA
  2. 2.M. D. Anderson Cancer CenterUniversity of TexasHoustonUSA
  3. 3.Winship Cancer InstituteEmory UniversityAtlantaUSA

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