Trial Summary
What is the purpose of this trial?
This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102 and nanoliposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you should discuss your current medications with the trial investigators to ensure they don't interfere with the study treatments.
What data supports the idea that TAS-102 + Nanoliposomal Irinotecan for Gastrointestinal Cancer is an effective treatment?
The available research shows that Nanoliposomal Irinotecan, when combined with other drugs like 5-fluorouracil and leucovorin, is effective for treating metastatic pancreatic cancer, especially after other treatments have failed. In a major study, this combination helped patients live about two months longer on average compared to those who didn't receive it. This suggests that the drug can be a valuable option for patients who have not responded to initial treatments.12345
What safety data exists for TAS-102 + Nanoliposomal Irinotecan in gastrointestinal cancer treatment?
Nanoliposomal irinotecan (nal-IRI), also known as Onivyde, has been evaluated for safety in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in metastatic pancreatic cancer and colorectal cancer. Studies indicate that this combination is effective and generally safe, but it is associated with certain adverse effects such as neutropenia, fatigue, diarrhea, and nausea/vomiting. These side effects may require dose adjustments and growth factor support. The NAPOLI-1 study showed that nal-IRI with 5-FU/LV significantly improved survival compared to 5-FU/LV alone, but close monitoring is necessary due to the potential for adverse events. Additionally, genetic testing for UGT1A1 polymorphisms is recommended to adjust dosing appropriately. In a rat model, a lipid nanoparticle formulation of irinotecan, Irinophore C™, was shown to reduce gastrointestinal toxicity compared to unformulated irinotecan. Overall, nal-IRI has an acceptable safety profile, but careful management of side effects is crucial.13678
Is the drug Nanoliposomal Irinotecan, Trifluridine and Tipiracil Hydrochloride a promising treatment for gastrointestinal cancer?
Yes, the drug Nanoliposomal Irinotecan, Trifluridine and Tipiracil Hydrochloride is promising for gastrointestinal cancer. It has shown improved effectiveness and safety in treating cancers like pancreatic and colorectal cancer. The drug uses a special delivery system that helps it stay in the body longer and target tumors better, while reducing side effects compared to traditional treatments.137910
Research Team
Olatunji Alese
Principal Investigator
Emory University
Eligibility Criteria
This trial is for adults with advanced gastrointestinal cancers that are metastatic or can't be surgically removed. Participants must have tried at least one prior therapy, have measurable disease per RECIST 1.1, and adequate organ function. They should not have had irinotecan before (for certain phases), no recent severe heart issues or infections, and cannot be pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Nanoliposomal Irinotecan (Anti-tumor antibiotic)
- Trifluridine and Tipiracil Hydrochloride (Anti-metabolites)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Dr. R. Donald Harvey
Emory University
Chief Medical Officer
MD from Emory University School of Medicine
Dr. George Painter
Emory University
Chief Executive Officer since 2013
PhD in Synthetic Organic Chemistry from Emory University
Taiho Oncology, Inc.
Industry Sponsor
Tim Whitten
Taiho Oncology, Inc.
Chief Executive Officer since 2018
MBA and Pharmacy degree
Harold Keer
Taiho Oncology, Inc.
Chief Medical Officer
MD, PhD
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