Back to resultsFOLFIRINOX in Patients With Inoperable Pancreatic Cancer
Primary Purpose
Adenocarcinoma of Pancreas
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Irinotecan, Oxaliplatin, Leucovorin, 5-FU
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of Pancreas focused on measuring Locally advanced unresectable adenocarcinoma of pancreas, Borderline resectable adenocarcinoma of pancreas
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
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFIRINOX
Arm Description
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.
Outcomes
Primary Outcome Measures
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
Secondary Outcome Measures
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)
Overall Survival
Number of Participants Who Experienced Toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01359007
Brief Title
FOLFIRINOX in Patients With Inoperable Pancreatic Cancer
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
The principal investigator terminated the study due to inactivity and low enrollment
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Pancreas
Keywords
Locally advanced unresectable adenocarcinoma of pancreas, Borderline resectable adenocarcinoma of pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFIRINOX
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Irinotecan, Oxaliplatin, Leucovorin, 5-FU
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.
Time Frame
2 years
Title
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)
Time Frame
2 years
Title
Overall Survival
Time Frame
2 years
Title
Number of Participants Who Experienced Toxicity
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shubham Pant, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FOLFIRINOX in Patients With Inoperable Pancreatic Cancer
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