RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Tumor and Stromal Subtypes on Efficacy of Neoadjuvant FOLFIRINOX in Subjects With Non-Metastatic Pancreatic Cancer

Quick Facts

Study Start:2019-06-12

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03977233

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:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Histologically or cytologically confirmed adenocarcinoma of the pancreas with no evidence of distant metastatic disease. * Subject has no evidence of co-morbidities precluding the potential to undergo surgical resection of PDAC as determined by surgical investigator. * Subjects must be willing to undergo a mandatory pre- and post-treatment EUS guided core biopsy of the pancreatic mass. * Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) resectable, borderline resectable or unresectable locally advanced PDAC. * Subject has adequate performance status as defined by ECOG performance status 0 or 1. * Subject has received no prior chemotherapy or chemoradiotherapy for pancreatic cancer. Subjects have not previously received surgery to remove pancreatic cancer. * Age ≥ 18 years of age. * Subject has adequate organ function at study entry, as demonstrated by: * Hemoglobin ≥ 9 g/dL * ANC ≥ 1.5 × 109/L * Platelets ≥ 100 × 109/L * Creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (as measured according to Cockcroft-Gault equation) * Total bilirubin ≤ 1.5 × ULN * AST/ALT ≤ 3 × ULN * GGT ≤ 5 × ULN. * Subject has life expectancy of at least 6 months. * Female subjects of childbearing potential must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX. * Female subjects of childbearing potential and male subjects must agree to use adequate contraception prior to study entry, for the duration of study participation, and 8 weeks after the end of treatment.	* Subject has any evidence of local recurrence or metastatic pancreatic cancer. * Other malignancies within the past 5 years except for adequately treated cervical or vulvar carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1). * Subject has hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to their excipients. * Subject has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. * Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Subjects are not permitted to participate in another investigational drug study while being treated on this protocol. * Subject has current evidence of any condition that makes participating in this study not in the best interest of the subject, including but not limited to: * Myocardial infarction within the past 6 months * New York Heart Association (NYHA) Class III or IV heart disease * Active infection requiring IV antibiotics * Subject has a history of or suspected Gilbert's syndrome or known homozygosity for UGT1A1\28 polymorphism (baseline testing not required). Subject has sensory peripheral neuropathy grade ≥ 2. * Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug. * Subject is unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of phenytoin, carbamazepine, phenobarbital, rifampin and rifabutin is discouraged, but not contraindicated. If subjects require phenytoin, carbamazepine or phenobarbital monitoring of drug levels is suggested during the study. * Subject is pregnant or lactating. * Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.

Inclusion Criteria

Exclusion Criteria

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Histologically or cytologically confirmed adenocarcinoma of the pancreas with no evidence of distant metastatic disease.
* Subject has no evidence of co-morbidities precluding the potential to undergo surgical resection of PDAC as determined by surgical investigator.
* Subjects must be willing to undergo a mandatory pre- and post-treatment EUS guided core biopsy of the pancreatic mass.
* Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) resectable, borderline resectable or unresectable locally advanced PDAC.
* Subject has adequate performance status as defined by ECOG performance status 0 or 1.
* Subject has received no prior chemotherapy or chemoradiotherapy for pancreatic cancer. Subjects have not previously received surgery to remove pancreatic cancer.
* Age ≥ 18 years of age.
* Subject has adequate organ function at study entry, as demonstrated by:
* Hemoglobin ≥ 9 g/dL
* ANC ≥ 1.5 × 109/L
* Platelets ≥ 100 × 109/L
* Creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (as measured according to Cockcroft-Gault equation)
* Total bilirubin ≤ 1.5 × ULN
* AST/ALT ≤ 3 × ULN
* GGT ≤ 5 × ULN.
* Subject has life expectancy of at least 6 months.
* Female subjects of childbearing potential must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX.
* Female subjects of childbearing potential and male subjects must agree to use adequate contraception prior to study entry, for the duration of study participation, and 8 weeks after the end of treatment.

* Subject has any evidence of local recurrence or metastatic pancreatic cancer.
* Other malignancies within the past 5 years except for adequately treated cervical or vulvar carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1).
* Subject has hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to their excipients.
* Subject has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
* Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Subjects are not permitted to participate in another investigational drug study while being treated on this protocol.
* Subject has current evidence of any condition that makes participating in this study not in the best interest of the subject, including but not limited to:
* Myocardial infarction within the past 6 months
* New York Heart Association (NYHA) Class III or IV heart disease
* Active infection requiring IV antibiotics
* Subject has a history of or suspected Gilbert's syndrome or known homozygosity for UGT1A1\*28 polymorphism (baseline testing not required).
* Subject has sensory peripheral neuropathy grade ≥ 2.
* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
* Subject is unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of phenytoin, carbamazepine, phenobarbital, rifampin and rifabutin is discouraged, but not contraindicated. If subjects require phenytoin, carbamazepine or phenobarbital monitoring of drug levels is suggested during the study.
* Subject is pregnant or lactating.
* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.

Contacts and Locations

Study Contact

Catherine Griffin, BS, BA

CONTACT

919-966-4432

catherine_griffin@med.unc.edu

Brian Burgess, BS

CONTACT

919-966-4432

brian_burgess@med.unc.edu

Principal Investigator

Ashwin Somasundaram, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

Ashwin Somasundaram, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

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

Study Start Date2019-06-12

Study Completion Date2030-01

Study Record Updates

Study Start Date2019-06-12

Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer Non-resectable
Pancreatic Cancer Resectable
neoadjuvant FOLFIRNOX
FOLFIRINOX
Pancreatic Cancer, Adult

Additional Relevant MeSH Terms

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