A Feasibility Study for Individualized Treatment of Patients With Advanced Pancreatic Cancer
- Establish tumor xenografts from patients with resectable adenocarcinoma of the pancreas
who undergo surgical resection at Johns Hopkins Hospital.
- Determine the activity of a series of 10 anticancer drugs against these tumors in ex
- Determine the response rate, time to treatment failure, and 6-month survival rate in
patients whose tumors were xenografted and treated in the mouse when treated with the
most active agent identified in that model.
- Define determinants of susceptibility and resistance to the drugs in xenografted
- Part I (surgical resection, tumor xenografts generation, and drug selection): Patients
undergo surgical resection. The resected tumor tissue is implanted in laboratory mice
to generate tumor xenografts. The mice are then treated with a series of 10 approved
anticancer drugs, whose anticancer activity are ranked from the most to the least
effective based on response of the tumor xenografts. The most effective drug is
identified for the individual patient. Patients for whom no drug is found to be
effective are removed from the study. Patients who develop progressive disease after
surgical resection and after mice data is available proceed to part II.
- Part II (individual patient treatment): Patients receive the most effective drug
identified in part I in the absence of disease progression or unacceptable toxicity.
The drugs may include bortezomib, capecitabine, cetuximab, docetaxel, erlotinib
hydrochloride, gemcitabine hydrochloride, irinotecan hydrochloride, mitomycin C,
sirolimus, or thalidomide.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the 6 months actuarial survival of patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model
Daniel A. Laheru, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government