A Phase II, Open-label Evaluating the Safety and Activity of naI-IRI in Combination with 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma

Purpose

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Eligibility

  • Must be at least 18 years of age.
  • A new clinical diagnosis of borderline resectable, previously untreated pancreatic adenocarcinoma confirmed by pathologic specimen evaluation
  • No clinical evidence of metastatic disease
  • Potentially resectable disease, as confirmed by CT or MRI of the abdomen
  • ECOG performance status of 0 or 1
  • Any biliary obstruction must have been treated.
  • Subjects with known or suspected Gilbert's disease must be formally tested for UGT1A1*28 with results available to study team prior to treatment initiation
  • Adequate organ function
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 6 weeks after the last dose of study drug to minimize the risk of pregnancy
  • Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 6 weeks following the last dose of study drug.

Contact

For additional study information, please contact Brittany Landsford:

Age

18 to 65
65 and over

Gender

Male
Female

Keywords

pancreatic cancer, tumor cells, FOLNapIRINOX

Principal Investigator

Thomas J George, Jr, M.D.

Department

HEMATOLOGY AND ONCOLOGY

Contact Information

bpolo6962@ufl.edu

352-733-0488


Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at CTSI-Studies-L@lists.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

For Research Teams