Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: Oxaliplatin; Irinotecan; 5-FU; Gemcitabine; Radiation Therapy
Intervention description: 75 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.; 150 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.; 2000 mg/m2 by vein over 46 hour continuous infusion, on Days 1 - 2 during weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.; 350 mg/m2 by vein every week for 5 doses beginning Day 1 (days 1, 8, 15, 22, 29).; External beam radiation therapy delivered 5 days/week +/- 2 days over 5.5 weeks with 18-MeV photons. 3D conformal RT, a total dose of 50.4 Gy 1.8 Gy/fraction (28 fractions).
Intervention MeSH terms: Gemcitabine; Fluorouracil; Oxaliplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Cancer; Adenocarcinoma of the Pancreas; High Risk Resectable; Borderline Resectable; Chemotherapy; Chemoradiation therapy; Oxaliplatin; Eloxatin; Irinotecan; CPT-11; Camptosar; 5-FU; 5-Fluorouracil; Adrucil; Efudex; Gemcitabine; Gemcitabine Hydrochloride; Gemzar; Radiation Therapy; XRT; RT; External Beam Radiation Therapy

Summary:

      The goal of this clinical research study is to learn if a chemotherapy combination called
      modified Folfirinox (or mFolfirinox), followed by a combination of gemcitabine and radiation
      therapy, followed by surgery, can help to control pancreatic cancer. The safety of this
      treatment will also be studied.

      mFolfirinox consists of 5-FU, oxaliplatin, and irinotecan. These 3 drugs, along with
      gemcitabine, are each designed to block the growth of cancer cells, which may lead to cancer
      cell death.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to
             treatment. Patients with Islet cell tumors are not eligible.

          2. Only untreated patients with high risk pancreatic adenocarcinomas will be eligible for
             the study. For this study, such patients are defined as those who meet one or more of
             the following radiographic or serologic criteria: a)Primary tumor that involves the
             superior mesenteric vein causing a vein deformity or segmental venous occlusion with a
             patent vessel above and below suitable for reconstruction. b)Primary tumor that
             involves </= 180 degrees of the superior mesenteric artery (SMA), celiac axis or any
             of its branches on CT or MRI. c) Primary tumor that abuts or encases (>/= 50% of the
             vessel circumference) a short segment of the common hepatic artery (typically at the
             gastroduodenal artery origin)

          3. (continuation of #2). d) Patients with a high CA19-9 (=/>500mg/dl) in the presence of
             a bilirubin =/< 2.0 mg/dL. e) Radiographic findings consistent with malignant
             peripancreatic lymphadenopathy outside the planned field on CT or MRI f) Radiographic
             findings of indeterminate liver or peritoneal lesions on CT or MRI concerning but not
             diagnostic of metastatic disease.

          4. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound
             (US), CT scan, MRI or laparotomy.

          5. There will be no upper age restriction; patients with Eastern Cooperative Oncology
             Group (ECOG) 0-1 are eligible.

          6. Adequate renal, and bone marrow function: a) Leukocytes >/= 3,000/uL. b) Absolute
             neutrophil count >/=1,500/uL.c) Platelets >/=100,000/Ul. d) Serum creatinine </= 2.0
             mg/dL.

          7. Hepatic function (endoscopic or percutaneous drainage as needed). a)Total bilirubin
             </= 2 X institutional upper limits of normal (ULN). b) AST (SGOT)/ALT (SGPT) </= 5 X
             institutional ULN.

          8. Patients must have no fever or evidence of infection or other coexisting medical
             condition that would preclude protocol therapy.

          9. Women of childbearing potential (defined as those who have not undergone a
             hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
             must agree to practice adequate contraception and to refrain from breast feeding.

         10. Patients must sign a study-specific consent form.

        Exclusion Criteria:

          1. Patients whose tumors are defined as locally advanced cancer or metastatic cancer are
             not eligible.

          2. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive
             heart failure; multiple comorbidity that preclude a major abdominal surgery.

          3. Known presence of metastases.

          4. Inability to comply with study and/or follow-up procedures.

          5. Patients < 18 years of age.

          6. Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this
             study.

          7. Patients with an active second malignancy with the exception of non-melanoma skin
             cancer.