This phase 2 trial is examining the effectiveness of TAS-102 (Lonsurf) plus oxaliplatin (Eloxatin) in the treatment of metastatic (spread to other parts of the body) colorectal cancer. The main outcome to be measured will be the overall response to the treatment rate. This study is being conducted in New Jersey, US.
The details
Colorectal cancer is the third most common cancer worldwide. A significant percentage of patients present with metastatic disease at diagnosis. Standard chemotherapy treatments have only limited effectiveness in treating advanced disease. Therefore, new treatment regimens are needed to improve treatment response on these patients.
TAS-102 (trifluridine–tipiracil) is an oral anti-cancer drug that shows to have a positive effect on survival in patients with rectal cancer. It also showed effectiveness when combined with chemotherapy drug oxaliplatin to treat advanced colorectal cancer. However, the effectiveness of this combined treatment in stage 4 colorectal cancer is still not known.
This trial is examining the effectiveness of TAS-102 plus oxaliplatin (TASOX) in the treatment of metastatic colorectal cancer. The main outcome to be measured will be the overall response and survival without cancer worsening.
Who are they looking for?
This trial will be recruiting 50 participants with stage 4 colorectal cancer. These patients must have spread cancer that has progressed after standard treatments. They must also have adequate blood cell counts and liver function and must be able to take oral medications. Patients who had previous chemotherapy treatment and recurred after 6 months can participate.
Patients must not be pregnant or breastfeeding, must not have had previous treatment with TAS-102, brain metastasis, or another cancer. They also must not have an active infection, major surgery within 4 weeks of the start of this trial, or anti-cancer therapy within 3 weeks of the start of this trial.
How will it work
All participants will receive TAS-102 orally on days 1 to 5 of a treatment cycle and oxaliplatin by injection over 2 hours on day 1. Treatment cycles repeat every 14 days until disease progression and/or unacceptable side effects. After treatment completion patients will be followed for up to 2 years.
The main outcomes to be measured will be the change in tumor response to the treatment, survival without cancer worsening, duration of response, and side effects.
