Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer

Summary

This is a research study to evaluate how the genetic makeup of Pancreatic Ductal Adenocarcinoma (PDAC) can affect the response to FDA-approved chemotherapy treatment, FOLFIRINOX, given before surgery to remove the tumor. Certain types of PDAC tumors can be surgically resected (removed). However, not all types of PDACs are resectable, especially if they are close to important structures like blood vessels or intestines. These types of PDACs are treated with chemotherapy such as FOLFIRINOX. Research studies showed that chemotherapy after surgical resection of PDAC tumors reduced the risk of the cancer returning.

Chemotherapy is used to treat PDAC that has not spread outside of the pancreas and is not resectable. FOLFIRINOX is a chemotherapy treatment that combines multiple chemotherapeutic agents, including oxaliplatin, leucovorin, irinotecan, and 5-FU. Patients receive these agents by intravenous infusion. Of these drugs, 5-FU requires you to return home with a chemotherapy pump that will deliver chemotherapy over 46 hours. This regimen has been studied in pancreatic cancer that has been removed with surgery as a method for preventing the cancer from returning. Studies showed FOLFIRINOX chemotherapy reduced the risk of cancer returning and increased patients survival. In this study, researchers want to know if FOLFIRINOX chemotherapy given before surgery will make the cancer easier to remove with surgery and increase the chances of the cancer staying away after surgery.

Researchers have shown that pancreatic cancers are not all the same when you look at the DNA and RNA that is inside a pancreatic cancer cell.

Depending on the expression of different genes in a cancer cell, some pancreatic cancers may respond differently to chemotherapy. In this study researchers want to know if FOLFIRINOX chemotherapy can change the genetic profile of the cancer. This will be studied by obtaining a biopsy of the cancer before the start of chemotherapy, and after 8 treatments of chemotherapy. They will also study cancer cells that will be collected from blood samples.

Conditions

• Pancreatic Ductal Adenocarcinoma (PDAC)
• Cancer of Pancreas
• Pancreatic Cancer, Adult
• Pancreas Adenocarcinoma
• Pancreatic Neoplasms
• Pancreatic Cancer Non-resectable
• Pancreatic Cancer Resectable

Interventions

DRUG

Oxaliplatin

85 mg/m2 in 250 cc Dextrose solution given by IV on Day 1 of each 14-day cycle

DRUG

Leucovorin

400 mg/m2 in 100 cc dextrose solution given with irinotecan by IV on Day 1 of each 14-day cycle

DRUG

Irinotecan Hydrochloride

180 mg/m2 in 500cc dextrose solution given with leucovorin by IV on Day 1 of each 14-day cycle

DRUG

5-FU

400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion on Day 1 of each 14-day cycle

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Ashwin Somasundaram, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-12

Primary Completion

2027-07-31

Completion

2030-01-31

FDA Drug

Yes

Countries

• United States

Study Locations