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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03977233
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    85 mg/m2 in 250 cc Dextrose solution given by IV on Day 1 of each 14-day cycle
  • Leucovorin — DRUG
    400 mg/m2 in 100 cc dextrose solution given with irinotecan by IV on Day 1 of each 14-day cycle
  • Irinotecan Hydrochloride — DRUG
    180 mg/m2 in 500cc dextrose solution given with leucovorin by IV on Day 1 of each 14-day cycle
  • 5-FU — DRUG
    400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion on Day 1 of each 14-day cycle

Study Details

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.

Key Dates

Start date
Jun 12, 2019
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jan 31, 2030

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SingleArm: FOLFIRINOX
    Subjects will receive FOLFIRINOX as an outpatient every 14 days per community standards of medical care. Protocol-based therapy will continue for 12 cycles (24 weeks) or until disease progression, unacceptable toxicity, study withdrawal, or subject death. Subjects will have the option of surgical resection after 8 cycles of therapy if repeat scans show evidence of resectable disease. The starting doses for mFOLFIRINOX regimen are: oxaliplatin 85 mg/m2, followed by leucovorin 400 mg/m2 given simultaneously with irinotecan 180mg/m2, followed by 5FU 400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion.

Primary Outcome Measure

Best disease control rate by Pancreatic ductal adenocarcinoma (PDAC) subtype [ Time Frame: 6 months after start of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Ashwin Somasundaram, MD
[email protected]
919-966-5902
Ashwin Somasundaram, MD (PRINCIPAL_INVESTIGATOR)
Jen Jen Yeh, MD (PRINCIPAL_INVESTIGATOR)
Hanna Sanoff, MD, PhD (SUB_INVESTIGATOR)
Michael S. Lee, MD (SUB_INVESTIGATOR)
Cheryl Carlson, MD, PhD (SUB_INVESTIGATOR)
Tammy Triglianos, RN, NP (SUB_INVESTIGATOR)
Ugwuji Maduekwe, MD (SUB_INVESTIGATOR)
Hong Jin Kim, MD (SUB_INVESTIGATOR)
Todd Baron, MD (SUB_INVESTIGATOR)

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By research site
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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