FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Condition: Locally Advanced Pancreatic Cancer; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: FOLFOXA
Intervention description: Schema:
1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG**
Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
Antiemetics will be administered as per standard institutional policy.
Intervention MeSH terms: Leucovorin; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to
      FOLFIRINOX for patients with metastatic pancreatic cancer and appears to be better tolerated
      with the ability to administer at least 10 cycles of therapy. Investigators therefore will
      evaluate FOLFOX-A in a phase II study for patient with locally advanced pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically or cytologically confirmed pancreatic ductal adenocarcinoma. Patients
             with pathology or cytology showing carcinoma of pancreas or adenosquamous of the
             pancreas are also eligible.

          -  Locally advanced pancreatic cancer, including patients defined by Callery19 as
             "unresectable" and "borderline resectable" are eligible:

          -  Measurable disease as per RECIST 1.1

          -  No prior chemotherapy for pancreatic cancer.

          -  No major surgery within 3 weeks of the start of study treatment. Patients must have
             recovered from the side effects of any major surgery at the start of study treatment.
             For questions on if a surgery is deemed "major," definition by surgeon can be used for
             clarification. Laparoscopy and central venous catheter placement are not considered
             major surgery.

          -  No prior invasive malignancy within the prior two years. However, patients with an
             early stage malignancy that is not expected to require treatment in the next 2 years
             (such as early stage, resected breast cancer or asymptomatic prostate cancer) are
             eligible.

          -  ECOG performance status 0 or 1.

          -  Age ≥ 18

          -  Not pregnant and not nursing. Women of child bearing potential must have a negative
             serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
             within 7 days prior to beginning of treatment. Post-menopausal women (surgical
             menopause or lack of menses >24 months) do not need to have a pregnancy test, please
             document status.

          -  Women of childbearing potential and sexually active males must use an effective
             contraception method 28 days prior to treatment, during treatment and for three months
             after completing treatment (men are to use contraception for six months post last dose
             of drug). Documentation of this being discussed required.

          -  Required Initial Laboratory Values:

               -  Neutrophils ≥ 1,500/mm3

               -  Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving
                  platelet transfusions within 7 days prior to laboratory sample)

               -  Hemoglobin > 9.0g/dL

               -  Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min

               -  Total bilirubin <1. 5 x ULN

               -  AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN

               -  Alkaline phosphatase < 2.5xULN. (Patients with elevated alkaline phosphatase,
                  total bilirubin, AST and ALT, who have subsequently undergone biliary stenting
                  and their liver tests are improving, do not need to wait for their alkaline
                  phosphatase to become < 2.5x ULN if their total bilirubin, AST and ALT have
                  improved to within required study levels and the alkaline phosphatase is
                  decreasing.)

        Exclusion Criteria:

          -  Patients with metastatic disease

          -  Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion
             would put the patient at risk if re-exposed

          -  Preexisting neuropathy is not allowed from any cause.

          -  Patients with serious medical risk factors involving any of the major organ systems
             such that the investigator considers it unsafe for the patient to receive FOLFOX-A

          -  Patients with unstable biliary stents or with plastic stents. Information on type of
             stent is required at registration.

          -  Patients with active infection or fever (patients on antibiotics for infection or
             patients getting over a cold or seasonal virus are not excluded), or known historical
             or active infection with HIV, hepatitis B, or hepatitis C.

          -  Patients with active sepsis or pneumonitis.

          -  Patients with a history of interstitial lung disease, history of slowly progressive
             dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis,
             pulmonary hypersensitivity pneumonitis or multiple allergies that in the
             investigator's opinion would put the patient at an increased risk.

          -  Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or
             uncontrolled) required at registration.