FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

Phase 2

Terminated

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
FOLFIRINOX	Irinotecan, Oxaliplatin, Leucovorin, 5-FU	Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.

Primary Outcome Measures

Name	Time	Method
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.	2 years

Secondary Outcome Measures

Name	Time	Method
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)	2 years
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.	2 years
Overall Survival	2 years
Number of Participants Who Experienced Toxicity	2 years