Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study
Condition: Pancreatic Adenocarcinoma; Poorly Differentiated Malignant Neoplasm; Resectable Pancreatic Cancer; Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage III Pancreatic Cancer; Undifferentiated Pancreatic Carcinoma
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms; Neoplasms
Intervention: Irinotecan Hydrochloride; Oxaliplatin; Leucovorin Calcium; Fluorouracil; Laboratory Biomarker Analysis
Intervention description: Given IV; Given IV; Given IV; Given IV; Correlative studies
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well combination chemotherapy works in treating patients with
      pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan
      hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in
      different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. Giving more than one drug
      (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of
      normal tissue that needs to be removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed carcinoma of the
             pancreas; most cases will be adenocarcinoma; cases with "undifferentiated" or "poorly
             differentiated" carcinoma will also be eligible

          -  There should be no evidence of metastatic disease on imaging of the chest, abdomen,
             and pelvis; this imaging should be either a contrast-enhanced computed tomography (CT)
             scan, or a contrast-enhanced magnetic resonance imaging (MRI) scan; positron emission
             tomography (PET) scans alone will not be adequate alternatives; there should be no
             evidence of occult metastatic disease in the abdomen, confirmed by laparoscopic
             examination

          -  The primary tumor must be resectable, defined as no involvement (abutment or
             encasement) of the major arteries (celiac, common hepatic, superior mesenteric) and
             interface between tumor and vessel (portal, superior mesenteric veins) wall to be less
             than 180 degrees of the circumference of the vessel wall; this should be confirmed by
             imaging of the abdomen, either by a contrast-enhanced computed tomography (CT) scan,
             or a contrast-enhanced magnetic resonance imaging (MRI) scan; PET scans will not be
             adequate alternatives; for each patient, the resectability must be reviewed by one of
             the study surgeons

          -  Patient must not have received any cancer-directed therapy (e.g., surgery,
             chemotherapy, radiation therapy, biologic therapy) for the index diagnosis

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Hemoglobin >= 10.0 g/dl

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Total bilirubin =< 1.5 X institutional upper limit of normal

          -  Serum creatinine within normal institutional limits, or creatinine clearance
             (calculated by Cockcroft-Gault) >= 60 mL/min/1.73 m^2 for patients with creatinine
             levels above institutional normal

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (double-barrier method of birth control or abstinence) for the duration of study
             participation and for 6 months after completing chemotherapy; should a woman become
             pregnant or suspect that she is pregnant while she or her partner is participating in
             this study, she should inform the treating physician immediately

          -  Subjects must have the ability to understand and the willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  Patients with uncontrolled intercurrent illness including, but not limited to ongoing
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Pregnant or breastfeeding women

          -  Pre-existing peripheral neuropathy (grade I or higher)