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

  • PHASE II STUDIES
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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.

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Authors and Affiliations

  1. Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA

    Bassel Fuad El-Rayes, Philip A. Philip, Fazlul H. Sarkar, Anthony F. Shields & Ann Marie Ferris

  2. M. D. Anderson Cancer Center, University of Texas, Houston, TX, USA

    Kenneth Hess, Ahmad O. Kaseb, Milind M. Javle, Gauri R. Varadhachary, Robert A. Wolff & James L. Abbruzzese

  3. Winship Cancer Institute, Emory University, 1365 Clifton Road NE, Atlanta, GA, 30322, USA

    Bassel Fuad El-Rayes

Authors
  1. Bassel Fuad El-Rayes
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  2. Philip A. Philip
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  3. Fazlul H. Sarkar
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  4. Anthony F. Shields
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  5. Ann Marie Ferris
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  6. Kenneth Hess
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  7. Ahmad O. Kaseb
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  8. Milind M. Javle
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  9. Gauri R. Varadhachary
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  10. Robert A. Wolff
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  11. James L. Abbruzzese
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Corresponding author

Correspondence to Bassel Fuad El-Rayes.

Additional information

This study was supported in part by Cancer Center Support Grant CA-22453 and Pancreas SPORE P20 CA101936 from the National Cancer Institute, Archer Daniel Midland Company and by OSI Pharmaceuticals.

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El-Rayes, B.F., Philip, P.A., Sarkar, F.H. et al. A phase II study of isoflavones, erlotinib, and gemcitabine in advanced pancreatic cancer. Invest New Drugs 29, 694–699 (2011). https://doi.org/10.1007/s10637-010-9386-6

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  • DOI: https://doi.org/10.1007/s10637-010-9386-6

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