Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
Condition: Resectable Pancreatic Cancer; Pancreatic Ductal Carcinoma
MeSH terms: Pancreatic Neoplasms; Carcinoma, Ductal; Carcinoma, Pancreatic Ductal
Intervention: FOLFIRINOX; Gemcitabine/nab-Paclitaxel; Radiation therapy; Capecitabine
Intervention MeSH terms: Paclitaxel; Gemcitabine; Capecitabine; Folfirinox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Resectable pancreatic cancer; Pancreatic Ductal Carcinoma

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.
    

Eligibility criteria:

        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 = ------------ (72) (serum creatinine
                       [mg/dL])

                    -  Creatinine clearance for females = 0.85 x male value

          -  The effects of radiation on the developing human fetus are known to be teratogenic.
             Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study treatment plus 30 days from the last date of study drug
             administration. Should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her treating physician immediately.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

        Patients who fulfill any of the following criteria will be excluded:

          -  The presence of metastatic disease on imaging or laparoscopy.

          -  Serious concomitant systemic disorders incompatible with the study (at the discretion
             of the investigator), such as significant cardiac or pulmonary morbidity e.g.
             congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias
             not well controlled with medication) or myocardial infarction within the last 12
             months, ongoing infection as manifested by fever.

          -  Pregnant or lactating women. Women of childbearing potential with either a positive or
             no pregnancy test (serum or urine) at baseline. (Postmenopausal woman must have been
             amenorrheic for at least 12 months to be considered of non-childbearing potential).

          -  Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.

          -  Diagnosis for other invasive carcinomas (except basal cell carcinoma/squamous cell
             carcinoma of the skin) within the last five years. Carcinoma in-situ is allowed.

          -  Other serious uncontrolled medical conditions that the investigator feels might
             compromise study participation.

          -  Unwillingness to participate or inability to comply with the protocol for the duration
             of the study.

          -  Participation in any investigational drug study within 4 weeks preceding the start of
             study treatment.

          -  History of uncontrolled seizures, central nervous system disorders or psychiatric
             disability judged by the investigator to be clinically significant, precluding
             informed consent, or interfering with compliance or oral drug intake.

          -  Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment,
             without complete recovery.