Details

Details

Title PREOPERATIVE FOLFIRINOX FOR RESECTABLE PANCREATIC ADENOCARCINOMA – A PHASE II STUDY

IRB CASE4214

CC 14-1289

Hospital Main Campus

Phase Phase 2

Disease Pancreas

Drug Folfirinox

Description

Description

Primary Objective
  • To determine feasibility of preoperative FOLFIRINOX for resectable pancreatic adenocarcinoma. Feasibility will be defined as the proportion of patients undergoing surgical resection after receiving at least 4 of the planned 6 cycles of preoperative FOLFIRINOX.
Secondary Objectives

To determine:

  • Safety and toxicity of preoperative FOLFIRINOX
  • Response rate
  • Proportion achieving major pathologic response - per CAP criteria
  • Proportion achieving R0 resection
  • Perioperative (30-day) mortality
  • The role of CA19.9 as potential prognostic and/or predictive biomarker
  • Progression-Free Survival
  • Overall Survival

Inclusion Criteria

Inclusion Criteria

  1. 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.
  2. 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. PET scans alone will not be adequate alternatives. There should be no evidence of occult metastatic disease in the abdomen, confirmed by laparoscopic examination.
  3. 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 180o 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 contrastenhanced 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.
  4. Patient must not have received any cancer-directed therapy (e.g., surgery, chemotherapy, radiation therapy, biologic therapy) for the index diagnosis.
  5. Age 18-75 years (both inclusive).
  6. ECOG Performance status 0-1 [See Appendix A].
  7. Patients must have adequate hematologic, hepatic, and renal function as defined below:
    • Hemoglobin ≥ 10.0 g/dl
    • Absolute neutrophil count ≥ 1,500/mm3
    • Platelet count ≥ 100,000/mm3
    • 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 m2 for patients with creatinine levels above institutional normal
  8. 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.
  9. Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria

Exclusion Criteria

  1. 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.
  2. Pregnant or breastfeeding women.
  3. Pre-existing peripheral neuropathy (grade I or higher).