This study focuses on individuals with Metastatic Colorectal Cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The research specifically looks at patients who have a certain genetic change known as a KRAS p.G12C mutation. This mutation is a specific alteration in the DNA of cancer cells that can influence how the disease grows and responds to therapy.
The purpose of the study is to compare the effectiveness of different medication combinations in preventing the cancer from getting worse. One group will receive a combination of sotorasib, panitumumab, and FOLFIRI. FOLFIRI is a treatment plan that includes fluorouracil, irinotecan hydrochloride trihydrate, and calcium folinate, all of which are administered through intravenous use, meaning they are delivered directly into a vein. Another group will receive FOLFIRI either alone or combined with bevacizumab.
Participants will be assigned to one of these treatment groups to see which approach is better at managing the disease. The study will follow the progress of the cancer over time to observe how long the treatments keep the disease from spreading further or increasing in size.
Who Can Join the Study?
You must have a confirmed diagnosis of metastatic colorectal adenocarcinoma, which is a type of cancer that started in the colon or rectum and has spread to other parts of the body.
A central laboratory must confirm that you have a specific genetic change called a KRAS p.G12C mutation, which is a change in the DNA of the cancer cells.
Your cancer must be measurable using standard medical rules, meaning the tumors are large enough to be clearly seen and tracked on scans.
If a tumor was previously treated with radiation (high-energy beams used to kill cancer cells), it can only be counted if it has grown larger since the treatment ended.
You must be at least 18 years old or the legal adult age in your country.
You must have an ECOG Performance Status of 1 or less, which means you are physically able to carry out most daily activities and are only slightly limited by your illness.
A doctor must believe that you have a life expectancy of more than 6 months.
You must have adequate hematologic and end organ function, meaning your blood counts and your major organs, such as your liver and kidneys, are working well.
You must be able to swallow oral medications (pills or liquids taken by mouth) and be willing to keep a daily record of when you take the study medicine.
Who Cannot Join the Study?
You have active, untreated brain metastases, which means cancer that has spread to the brain and is currently growing and has not yet been treated.
You have leptomeningeal disease, which is a condition where cancer cells have spread to the thin protective layers that surround the brain and spinal cord.
You have previously taken a KRAS p.G12C inhibitor, which is a specific type of medicine designed to block a certain protein that helps cancer grow.
You have had to lower your dose or delay your treatment when taking 5-fluorouracil (5-FU) or irinotecan in any past chemotherapy treatments because of toxicity, which refers to harmful or unpleasant side effects caused by medication.
You have a history of interstitial pneumonitis or pulmonary fibrosis, which are conditions involving inflammation or scarring of the lung tissue, or if these conditions are visible on your initial CT scan (a special type of X-ray image used to look inside the body).
Panitumumab is a targeted therapy given through a vein that works by blocking certain signals that help cancer cells grow and divide.
Fluorouracil is a chemotherapy drug administered through a vein that works by interfering with the DNA of cancer cells, preventing them from multiplying.
Irinotecan is a chemotherapy medication given through a vein that helps stop the growth of cancer cells by blocking a specific enzyme that cancer cells need to replicate.
Sotorasib is an oral medication designed to target and block a specific mutated protein that helps cancer cells survive and grow.
Calcium folinate is a substance given through a vein that is used alongside certain chemotherapy drugs to help reduce their side effects and improve their effectiveness.
Bevacizumab is a therapy given through a vein that works by blocking the growth of new blood vessels that tumors need to receive nutrients and oxygen.
Colorectal cancer – This is a type of cancer that begins in the colon or the rectum. It often starts as small, noncancerous growths called polyps on the inner lining of the digestive tract. Over time, these polyps can undergo genetic changes and transform into malignant tumors. As the disease progresses, the cancer cells can grow into nearby tissues and potentially spread to other parts of the body.
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