FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

NCT ID: NCT01359007

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-10-31

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.

Conditions

Adenocarcinoma of Pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Irinotecan, Oxaliplatin, Leucovorin, 5-FU

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shubham Pant, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

1977

Identifier Type: -

Identifier Source: org_study_id