FOLFIRINOX in Patients With Inoperable Pancreatic Cancer
Condition: Adenocarcinoma of Pancreas
MeSH terms: Adenocarcinoma
Intervention: Irinotecan, Oxaliplatin, Leucovorin, 5-FU
Intervention description: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Intervention MeSH terms: Leucovorin; Oxaliplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Locally advanced unresectable adenocarcinoma of pancreas; Borderline resectable adenocarcinoma of pancreas

Summary:

      The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and
      the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging
      sufficient to allow surgical resection, could improve the overall survival of patients with
      locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic
      cancer, a phase II study of this regimen in patients with locally advanced unresectable and
      borderline pancreatic cancer is planned to determine the rate of conversion to operability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed locally advanced unresectable or borderline
             resectable adenocarcinoma of pancreas

          -  Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must
             have occurred within 4 weeks prior to study entry

          -  No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans

          -  Male or non-pregnant and non-lactating female age > or equal to 18 years and < or
             equal to 70 years of age

          -  Patient must have received no prior therapy for the treatment of locally advanced
             unresectable or borderline resectable pancreatic cancer

          -  Patients must have adequate blood counts at baseline and blood chemistry levels

          -  Patient has ECOG Performance Status 0 to 1

        Exclusion Criteria:

          -  Patients with islet cell neoplasms excluded

          -  Patients with known brain metastases

          -  Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)

          -  Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
             therapy

          -  Known infection with HIV, hepatitis B or hepatitis C

          -  Major surgery or vascular device placement within 4 weeks prior to Day 1 of treatment
             in study

          -  Prior chemotherapy or radiation for pancreatic cancer

          -  History of allergy or hypersensitivity to the study drugs

          -  Patient is enrolled in any other clinical protocol or investigational trial

          -  Metastatic disease on radiological staging

          -  Prior malignancy within last 3 years

          -  Significant cardiac disease

          -  Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal
             radiation in which in opinion of the investigator may place the patient at increased
             risk

          -  peripheral sensory neuropathy > or equal to grade 2 at baseline