BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: FOLFOXA
Intervention MeSH terms: Leucovorin; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic pancreatic cancer; pancreatic cancer; metastatic

Summary:

      A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved
      chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you
      will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and
      Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®.
      Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with
      the other 3 drugs is being investigated. Your doctors are studying the activity and side
      effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pathologically or cytological confirmed pancreatic ductal adenocarcinoma. Patients
             with pathology or cytology showing carcinoma of pancreas or adenosquamous of the
             pancreas are also eligible.

          2. Metastatic advanced disease.

          3. No prior chemotherapy for pancreatic cancer

          4. 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.

          5. 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.

          6. ECOG performance status 0 or 1.

          7. Age ≥ 18

          8. 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 >12 months) do not need to have a pregnancy test, please
             document status.

          9. Women of childbearing potential and sexually active males must use an effective
             contraception method during treatment and for three months after completing treatment.
             Documentation of this being discussed required.

         10. Required Initial Laboratory Values:

               -  Neutrophils ≥ 1,500/mm3

               -  Platelet count ≥ 100,000/mm3

               -  Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min

               -  Total bilirubin ≤ 1.25 x ULN

               -  AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN (for patients with liver metastases, AST&ALT
                  < 5xULN)

               -  Alkaline phosphatase < 2.5xULN, unless bone metastasis is present and in the
                  absence of liver metastasis

        Exclusion Criteria:

          1. Patients with known brain metastases

          2. Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion
             would put the patient at risk if re-exposed

          3. Preexisting neuropathy

          4. 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 5.
             Patients with unstable biliary stents or with plastic stents. Information on type of
             stent is required at registration.

        6. 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.

        7. Patients with sepsis or pneumonitis. 8. 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.

        10. Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or
        uncontrolled) required at registration.