Window of Opportunity for Neoadjuvant Stroma Modification in Pancreatic Cancer
Fox Chase Cancer Center
Summary
This proposal will investigate the effect of paricalcitol, hydroxychloroquine, and losartan (PHL) combination of 3 stroma-modifying drugs on pancreatic adenocarcinoma and its stroma.
Description
This study will test the feasibility and safety of these pancreatic ductal adenocarcinoma (PDAC) stroma modulators in the pre-operative setting, and will offer the opportunity to detect the combined effect on PDAC tissue constituents to validate the mechanism using real-time biologic end points. The long-term goal for PHL is to deploy this regimen in combination with chemotherapy to treat PDAC. Further, this study will establish a paradigm of a "window" trial (the use of novel therapies in the period of time between the end of neoadjuvant treatment and surgery) to test new compounds and establ…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria for all study participants: * Patients must have new diagnosed histologically or cytologically confirmed pancreatic adenocarcinoma. * Patients must have resectable non-metastatic PDAC and anticipate receiving surgery in a minimum of 4 weeks and a maximum of 12 weeks from completing neoadjuvant chemotherapy and radiation. * Patients are planned for a minimum of 3 months of modified FOLFIRINOX treatment followed by chemo/radiation followed by surgical resection. * Age \> 18 years. * ECOG performance status 0-1 * Patients must have normal organ function as defined below * Tota…
Interventions
- Combination ProductParicalcitol, Hydroxychloroquine, Losartan
Paricalcitol 25 mcg IV administered M-W-F Hydroxychloroquine 600 mg PO BID Losartan 50 mg PO daily
- OtherNeoadjuvant therapy and surgery only (Control)
Control arm These patients will proceed to surgery at completion of neoadjuvant therapy.
Location
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania