Study on Tumor Types in Patients Receiving FOLFIRINOX for Non-Metastatic Pancreatic Cancer

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03977233

Provider View

This study is exploring how the genetic makeup of pancreatic cancer affects the response to a chemotherapy treatment called FOLFIRINOX, which is given before surgery to remove the tumor. The research aims to see if this treatment can make the cancer easier to remove and prevent it from coming back.

Patient Parameters

Program Overview

This research is focused on understanding how different genetic types of pancreatic cancer respond to a chemotherapy treatment called FOLFIRINOX, which is used before surgery. FOLFIRINOX is a combination of several drugs given through an IV, and one of these drugs requires a pump to deliver it over 46 hours at home. The study will look at whether this treatment can make tumors easier to remove and help prevent the cancer from returning. Researchers will study the cancer's genetic profile by taking a biopsy before and after chemotherapy, and they will also analyze cancer cells from blood samples.

Description

This clinical trial is designed to see how different types of pancreatic cancer respond to FOLFIRINOX chemotherapy given before surgery. The study will involve taking a biopsy of the pancreas before starting treatment and after eight cycles of chemotherapy. Imaging tests will be done every four cycles to check if the cancer can be surgically removed. If the cancer responds well, surgery may be performed after eight cycles, followed by four more cycles of chemotherapy.

The treatment will continue unless:

  • The cancer progresses
  • A new illness prevents further treatment
  • Side effects become unacceptable
  • The patient decides to leave the study
  • The doctor decides it's not safe to continue

Patients will be followed for up to 36 months after treatment or until they pass away, whichever comes first. If a patient leaves the study due to side effects, they will be monitored until the side effects improve or stabilize.

Eligibility Criteria

Inclusion Criteria

  • Must agree to participate and allow access to personal health information.
  • Have a confirmed diagnosis of pancreatic cancer that hasn't spread.
  • Be eligible for surgery based on health status.
  • Agree to have a biopsy before and after treatment.
  • Have pancreatic cancer that can be measured or evaluated.
  • Be in good health with a performance status of 0 or 1.
  • Have not received prior chemotherapy or surgery for pancreatic cancer.
  • Be 18 years or older.
  • Have adequate organ function as shown by specific blood tests.
  • Have a life expectancy of at least 6 months.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
  • Men must agree to use contraception during and after the study.

Exclusion Criteria

  • Have recurrent or metastatic pancreatic cancer.
  • Have had other cancers in the past 5 years, except for certain treated skin or cervical cancers.
  • Have allergies to any of the chemotherapy drugs used in the study.
  • Have a known enzyme deficiency affecting drug metabolism.
  • Have participated in another drug study within 4 weeks before starting this study.
  • Have a condition that makes participation unsafe, such as recent heart attack or severe heart disease.
  • Have a history of certain genetic conditions affecting drug metabolism.
  • Have severe nerve damage.
  • Have had major surgery or injury within 4 weeks of starting the study.
  • Are unable to stop using certain medications.
  • Are pregnant or breastfeeding.
  • Have conditions that may affect compliance with the study.

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