Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer
- Determine the 6-month survival rate of patients with locally advanced or metastatic
pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib
- Determine the frequency of objective tumor response rate in these patients.
- Determine the time to treatment failure in these patients.
- Determine the effect of baseline expression of pAKT and activation of NF-kappaB on
survival of patients treated with this regimen.
- Determine the overall time to disease progression in these patients.
- Estimate the quantitative and qualitative toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral genistein twice daily on days -7 to 28 in course 1 and on days 1-28 in
all other courses. Patients also receive gemcitabine hydrochloride IV over 30 minutes on
days 1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
at 6 months
Khaldoun Almhanna, MD
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|