TAS-102 + Oxaliplatin for Colon Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any other investigational agents or have had anticancer therapy within the last 3 weeks before starting the study.
What data supports the effectiveness of the drug TAS-102 combined with Oxaliplatin for colon cancer?
Research shows that TAS-102, when used alone, extended the survival of patients with advanced colorectal cancer by about 2 months compared to a placebo. Additionally, combining TAS-102 with Oxaliplatin has been shown in early studies to enhance anti-tumor activity compared to using either drug alone.12345
Is the combination of TAS-102 and Oxaliplatin safe for humans?
What makes the drug TAS-102 + Oxaliplatin unique for colon cancer treatment?
The combination of TAS-102 and Oxaliplatin is unique because it combines a novel platinum-based drug, Oxaliplatin, which is effective even in tumors resistant to other platinum drugs, with TAS-102, a mixture that includes trifluridine, which interferes with cancer cell DNA, and tipiracil, which helps maintain trifluridine levels. This combination may offer a new option for patients who have not responded to other treatments.910111213
What is the purpose of this trial?
This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, 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.
Research Team
Howard S. Hochster
Principal Investigator
Rutgers Cancer Institute of New Jersey
Eligibility Criteria
This trial is for adults with stage IV colon cancer that's worsened after standard treatment. They should have had a reaction to previous treatments, measurable disease, specific genetic features (RAS mutation and MMR status), good physical function, and acceptable blood counts. They must not be pregnant or breastfeeding, have no major recent surgery or active infections, and can't have used TAS-102 before.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TAS-102 orally twice daily on days 1-5 and oxaliplatin intravenously on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Oxaliplatin
- TAS-102
Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
National Cancer Institute (NCI)
Collaborator