FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

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.

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 Overview

• Status: Terminated
• Conditions: Adenocarcinoma of Pancreas
• Intervention / Treatment: Drug: Irinotecan, Oxaliplatin, Leucovorin, 5-FU

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Irinotecan, Oxaliplatin, Leucovorin, 5-FU; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Shubham Pant, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Locally advanced unresectable adenocarcinoma of pancreas; Borderline resectable adenocarcinoma of pancreas
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protective Agents; Topoisomerase Inhibitors; Micronutrients; Vitamins; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Oxaliplatin; Leucovorin; Irinotecan
• Other Study ID Numbers: 1977 (University of California, Irvine)