A Phase II Study Evaluating the Rate of R0 Resection (Microscopically Negative Margins) After Induction Therapy With 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan (FOLFIRINOX) in Patients With Borderline Resectable or Locally Advanced Inoperable Pancreatic Cancer.
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