Evaluating tumor types in pancreatic cancer patients receiving FOLFIRINOX treatment
Impact of Tumor and Stromal Subtypes on Efficacy of Neoadjuvant FOLFIRINOX in Subjects With Non-Metastatic Pancreatic Cancer
This study is testing how different types of pancreatic cancer respond to the chemotherapy FOLFIRINOX before surgery to see if it helps make the tumors easier to remove.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT03977233 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess how different genetic subtypes of Pancreatic Ductal Adenocarcinoma (PDAC) influence the effectiveness of the chemotherapy regimen FOLFIRINOX, administered before surgery. Participants will undergo a biopsy of the pancreatic tumor before and after eight cycles of treatment to evaluate changes in tumor characteristics. Imaging will be conducted every eight weeks to determine if the tumor has become resectable. If a positive response is observed, surgery may be performed after the initial treatment cycles.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed PDAC who have not received prior chemotherapy and are classified as having resectable, borderline resectable, or unresectable locally advanced disease.
Not a fit: Patients with distant metastatic disease or those who have previously undergone chemotherapy or surgery for pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with pancreatic cancer, potentially improving surgical outcomes.
How similar studies have performed: Other studies have shown promising results with similar chemotherapy approaches in pancreatic cancer, but this specific evaluation of tumor subtypes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. * Subject has life expectancy of at least 6 months. 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. Subjects participating in other clinical trials that are receiving SOC FOLFIRINOX are permitted on study. * 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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ashwin Somasundaram, MD — University of North Carolina, Chapel Hill
- Study coordinator: Catherine Griffin, BS, BA
- Email: catherine_griffin@med.unc.edu
- Phone: 919-966-4432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.