Liposomal Irinotecan + FOLFOX for Pancreatic Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop using strong CYP3A4 inhibitors or inducers before joining. If you're on these medications, you'll need to discuss with your doctor about stopping them.
What data supports the effectiveness of the drug Liposomal Irinotecan + FOLFOX for treating pancreatic cancer?
Is the combination of Liposomal Irinotecan and FOLFOX safe for treating pancreatic cancer?
The combination of Liposomal Irinotecan and 5-fluorouracil (5-FU) has been shown to be effective and generally well-tolerated in patients with advanced pancreatic cancer, although some patients may experience significant blood-related side effects. Modified versions of similar treatments have been developed to improve safety by reducing certain toxicities.16789
What makes the drug Liposomal Irinotecan + FOLFOX unique for treating pancreatic cancer?
Liposomal Irinotecan + FOLFOX is unique because it uses a special formulation of irinotecan encapsulated in a lipid layer, which helps improve its effectiveness and safety compared to the non-liposomal version. This drug combination is particularly beneficial for patients with metastatic pancreatic cancer who have already been treated with gemcitabine-based therapies, offering a new option when other treatments have failed.35101112
What is the purpose of this trial?
This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or 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.
Research Team
Thomas George, MD
Principal Investigator
University of Florida
Eligibility Criteria
Adults with a new diagnosis of resectable or borderline resectable, untreated pancreatic adenocarcinoma. Participants must have good performance status, treated biliary obstruction if present, no metastatic disease, and adequate organ function. Women and men must use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive liposomal irinotecan with FOLFOX in 8 cycles, each cycle lasting 14 days
Surgery
Participants undergo surgical resection to achieve complete surgical resection (R0)
Follow-up
Participants are monitored for post-operative complications and overall response rate
Treatment Details
Interventions
- 5-FU
- Liposomal Irinotecan
- Oxaliplatin
5-FU is already approved in United States, European Union, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Skin cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Ipsen
Industry Sponsor
David Loew
Ipsen
Chief Executive Officer since 2020
BA in Business Administration and MBA from the University of St. Gallen, Switzerland
Sandra Silvestri
Ipsen
Chief Medical Officer since 2023
MD, PhD