This phase 3 trial is examining the effectiveness of arfolitixorin versus leucovorin (folinic acid) when added to a combined treatment with 5-fluorouracil, oxaliplatin, and bevacizumab (FOB) to treat advanced colorectal cancer. The main outcome to be measured is the cancer response to the treatment.
Treatment with FOB is recommended as the first line treatment for patients with advanced colorectal cancer. Other agents may be added to treatment to increase the response. Prior studies showed that arfolitixorin increased the effectiveness of FOB in patients with colorectal cancer. However, the effect of this agent in the treatment of metastatic (spread to other parts of the body) colorectal cancer is still not clear.
The main outcome to be measured is the overall response rate by measuring the best response from start to end of the treatment.
Who are they looking for?
This trial is looking for 440 participants with advanced colorectal cancer. Patients must have normal blood cell counts and adequate liver and kidney function tests. Patients of childbearing age must use effective contraceptive methods
Patients should have had the last cancer treatment at least 6 months before the start of this study. Patients must not have any other tumors or prior treatment with arfolitixorin. Must not have bowel, heart disease, any active infection, psychiatric illness or ongoing drug or alcohol abuse.
How will it work
There will be two groups for this study. Patients will be randomly assigned to receive FOB treatment in combination with either arfolitixorin or leucovorin. Treatment response will be measured before and after treatment.
The main outcomes measured will be the response to treatment, duration of response and survival time without the tumor growing or spreading.