Perioperative FOLFIRINOX For Patients With Resectable Pancreatic Adenocarcinoma: A Pilot Study

Study Overview

Perioperative FOLFIRINOX for Patients With Resectable Pancreatic Adenocarcinoma: A Pilot Study

The purpose of this study is to see whether it is possible to give 8 doses of a combination of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be removed with surgery.

Primary Objective: To evaluate the percentage of pancreatic cancer patients able to complete the full 4 months of preoperative chemotherapy and undergo a resection. Secondary Objectives * To assess the percentage of patients able to complete all therapy, including preoperative chemotherapy, surgery, and postoperative therapy. * To assess treatment-related toxicity during preoperative therapy * To assess intra-operative and post-operative complications * To assess the histopathologic (R0/R1) resection rate after preoperative therapy * To determine disease free survival (DFS) for patients who undergo resection. * To determine progression free survival (PFS) for all patients * To determine overall survival (OS) from the date of first treatment

Pancreatic Ductal Adenocarcinoma (PDAC)

DRUG: FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)

IRB15-1630

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-05-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-03-15
First Submitted that Met QC Criteria 2016-05-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-03-19
First Posted (ACTUAL) 2016-05-25	Results First Posted N/A	Last Verified 2019-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FOLFIRINOX+surgery 4 cycles of pre-operative FOLFIRINOX, followed by surgery, followed by 2 more cycles of FOLFIRINOX	DRUG: FOLFIRINOX (oxaliplatin, leucovorin, irinotecan) FOLFIRINOX administered preoperatively and postoperatively

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFIRINOX+surgery

4 cycles of pre-operative FOLFIRINOX, followed by surgery, followed by 2 more cycles of FOLFIRINOX

DRUG: FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)

FOLFIRINOX administered preoperatively and postoperatively

Primary Outcome Measures	Measure Description	Time Frame
Percentage of patients able to complete 4 months of preoperative chemotherapy and undergo a resection	Measured by percentage of successes/failures	4 months

Secondary Outcome Measures	Measure Description	Time Frame
The extent of preoperative chemotherapy, surgery, and adjuvant chemotherapy.	Reported as a yes/no for each element of therapy.	6 months
Presence of adverse events	Presence of grade 3 and 4 toxicities measured according to NCI CTCAE version 4.0.	6 months
Intraoperative and post-op complications	Any unexpected events as determined by surgical oncologist	Within 6 weeks post surgery
R0/R1 resection rates	Measured as proportion of patients with microscopic negative and microscopic residual tumor margin	6 months
Disease free survival	Defined by date from surgical resection to radiographic recurrence or death	Up to 5 years
Progression free survival	Defined by radiographic progression by RECIST criteria or death	Up to 5 years
Overall survival	Defined by date from Cycle 1 Day 1 of preoperative chemotherapy to death from any cause.	Up to 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

No extra-pancreatic disease, aside from lymphadenopathy
No arterial tumor contact (celiac axis, superior mesenteric artery, or common hepatic artery)
No tumor contact with the superior mesenteric vein or portal vein or ≤ 180° contact without vein contour irregularity 3. Confirmation of resectability by surgical oncology consultation. 4. No previous therapy for pancreatic cancer 5. Short removable metal stents rather than plastic stents are strongly encouraged but not required for palliation of initial obstructive jaundice 6. ECOG performance status of 0 or 1 (Appendix 1) 7. Age > 18 years 8. No CVA within 6 months, no MI within 6 months 9. The effects of mFOLFIRINOX on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 10. Negative pregnancy test in females of reproductive age 11. Anticoagulation is permitted but patients may not be on warfarin. 12. Patients must have normal organ and marrow function as defined below:

absolute neutrophil count >1,500/mcL
platelets >100,000/mcL
total bilirubin < 1.5X upper limits of normal
AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
creatinine within normal institutional limits OR
creatinine clearance >60 mL/min/ per Cockroft-Gault equation for patients with creatinine levels above institutional normal. 13. Ability to understand and the willingness to sign a written informed consent document.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Hedy Kindler, M.D., University of Chicago

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record