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
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.
- 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.
For additional study information, please contact Brittany Landsford:
Keywordspancreatic cancer, tumor cells, FOLNapIRINOX
Principal InvestigatorThomas J George, M.D.
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