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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- University of Oklahoma
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
FOLFIRINOX
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.
Intervention: Irinotecan, Oxaliplatin, Leucovorin, 5-FU (Drug)
Outcomes
Primary Outcomes
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
Time Frame: 2 years
Secondary Outcomes
- 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)