Combination Chemotherapy for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.
Will I have to stop taking my current medications?
The trial requires that you stop using strong inducers or inhibitors of CYP3A4 (a type of enzyme that affects drug metabolism) at least 2 weeks before starting the study treatment.
Is the combination chemotherapy for colorectal cancer safe for humans?
The combination of trifluridine/tipiracil (TAS-102) and bevacizumab has been studied in patients with metastatic colorectal cancer and is generally considered to have controllable safety, though it can cause side effects like nausea and vomiting. These treatments have been evaluated in various studies, showing that while they can be effective, they may also lead to common treatment-related adverse events (unwanted effects).12345
What makes the drug combination of Bevacizumab, Liposomal irinotecan, and TAS102 unique for treating colorectal cancer?
This drug combination is unique because it combines TAS-102 (trifluridine and tipiracil) with bevacizumab, which has shown enhanced activity against colorectal cancer compared to using either drug alone. It is particularly beneficial for patients with metastatic colorectal cancer who have not responded to standard therapies, offering a feasible late-line treatment option that can prolong survival.46789
What data supports the effectiveness of the drug combination for colorectal cancer?
Who Is on the Research Team?
Dustin Deming, M.D.
Principal Investigator
UW Carbone Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with metastatic colorectal cancer that's resistant to standard treatments. They must have tried certain chemotherapies and, if applicable, targeted therapies based on their cancer's genetic features. People can't join if they have specific mutations (BRAF V600), high microsatellite instability, or are using strong CYP3A4 affecting drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive liposomal irinotecan, TAS102, and bevacizumab for metastatic colorectal cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Liposomal irinotecan
- TAS102
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
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