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

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Jun 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how the genetic characteristics of pancreatic cancer can influence how well patients respond to a specific chemotherapy treatment called FOLFIRINOX. This treatment is given to patients with non-metastatic pancreatic cancer before they undergo surgery to remove the tumor. The researchers want to find out if chemotherapy can make the tumors easier to remove during surgery and help lower the chances of the cancer coming back after surgery. By analyzing cancer cells from both biopsies and blood samples, the study aims to understand if FOLFIRINOX can change the genetic profile of the cancer cells.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with pancreatic cancer that has not spread to other parts of the body. They should not have received any prior chemotherapy or surgery for their cancer. Participants will need to provide written consent and agree to have biopsies taken before and after treatment. Throughout the study, patients will receive FOLFIRINOX through intravenous infusions, and they may need to use a portable pump for one of the drugs. This trial aims to gather valuable information that could improve treatment strategies for pancreatic cancer in the future.

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Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.