Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Rese… (NCT02243007) | Clinical Trial Compass
TerminatedPhase 2
Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
Stopped: Slow Accrual
United States7 participantsStarted 2014-09
Plain-language summary
This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to study entry.
* No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan (or MRI with gadolinium and/or manganese) and laparoscopy. All patients must be staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or abdominal MRI with gadolinium and/or manganese). Only potentially resectable patients are eligible. Potentially resectable is defined as a) no extrapancreatic disease, b) no evidence (on CT) of involvement of the celiac axis or SMA, c) no evidence (CT or MRI) of occlusion of the SMV or SMPV confluence, and d) no evidence of gross peritoneal or distant metastases by laparoscopy.
* Patients must be 18 years old or older. There will be no upper age restriction.
* ECOG Performance Status of 0 or 1 are eligible.
* Life expectancy of greater than 3 months.
* Lab Values:
* ANC ≥ 1500 cells/mm3
* Platelet count at least 100,000 cells/mm3.
* AST and ALT ≤2.5 x upper limit of normal
* Total Bilirubin ≤ 5 x upper limit of normal if patient is s/p biliary stenting AND decreasing at least two time points after stenting.
* Total Bilirubin ≤ 1.5 x upper limit of normal if no biliary stenting was done
* Serum Creatinine ≤1.5mg/dl OR
* Creatinine Clearance greater than or equal to 30ml/min (as estimated by Cockroft Gault Equation) (140 - age \[yrs\]) (body wt \[kg\])
* Creatinine clearance for males = --------…