This phase 2 study recruiting in New York aims to determine the effectiveness of regorafenib (Stivarga) in patients with metastatic colorectal cancer. The main outcome will be time to disease progression.
The details
The standard treatment for metastatic (spread to other areas of the body) colorectal cancer is a combination of chemotherapies. Regorafenibis a chemotherapy agent generally used in metastatic colorectal cancer that has progressed despite other treatments. It has previously been shown to improve progression-free survival of metastatic colorectal cancer patients. An improvement in overall survival has also been shown.
The current trial aims to determine whether regorafenib is effective in newly diagnosed metastatic colorectal cancer. The effectiveness will be measured by progression-free survival (time from treatment until disease progression) and overall survival (time from treatment until death from any cause).
Who are they looking for?
This trial will recruit 12 patients who have not been previously treated for metastatic colorectal cancer or have progressed despite treatment with a chemotherapy regimen containing 5-fluorouracil. Participants must have a life expectancy of at least 3 months. Participants must have normal blood values and adequate kidney and liver function.
Participants must not have uncontrolled high blood pressure or heart disease (including congestive heart failure, cardiovascular disease, or angina). Patients who have a heart attack in the 6 months preceding the trial will be excluded. Participants must not have HIV, hepatitus B or C, or other active infection. Women must not be pregnant or breastfeeding, and participants must be willing to use contraception.
How will it work
All participants will be treated with regorafenib. Each treatment cycle will consist of 3 weeks daily treatment, followed by one week without treatment. The treatment dose will be raised to 120 mg in the second week of the first cycle. Patients will be assessed for negative side effects after the dosage increase. If the effects are not severe, participants will remain on this dose. Patients will be evaluated for response after every 2 cycles (8 weeks). The patient’s progression-free survival and overall survival will be measured.
