Study of 5-Fluorouracil, Panitumumab, and Sotorasib for Patients with Advanced KRAS G12C Mutated Colorectal Cancer Not Eligible for Standard Chemotherapy
This clinical trial is focused on studying a type of cancer called colorectal cancer, which affects the colon or rectum. The study is specifically for patients with a mutation known as KRAS G12C in their cancer cells. The trial will test a combination of treatments to see how effective they are in managing this type of cancer. The treatments being studied include 5-fluorouracil, a medication that helps stop cancer cells from growing, Panitumumab, which is an anti-EGFR drug that targets specific proteins on cancer cells, and Sotorasib, a drug that specifically targets the KRAS G12C mutation.
The purpose of the study is to evaluate how well these treatments work together in patients who cannot undergo more aggressive chemotherapy options. Participants will receive these medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will last for up to 24 months, during which the patients will be monitored regularly to assess the progression of their cancer and any side effects they may experience. The goal is to see if the combination of these treatments can help patients live longer without their cancer getting worse.
Throughout the study, the health and quality of life of the participants will be closely observed. This includes regular imaging tests to check the status of the cancer and questionnaires to understand how the treatments are affecting the patients’ daily lives. The study aims to provide valuable information on the effectiveness of this treatment combination for patients with advanced colorectal cancer that has the KRAS G12C mutation.
1initial visit
Upon joining the study, an initial visit is scheduled. During this visit, a healthcare professional will explain the study procedures and answer any questions. Consent forms are signed to confirm understanding and agreement to participate.
A series of tests and assessments are conducted to confirm eligibility. These may include blood tests, imaging scans, and a review of medical history.
2treatment initiation
The treatment begins with the administration of 5-fluorouracil, panitumumab, and sotorasib. 5-fluorouracil is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.
Panitumumab is also administered as an intravenous infusion. This medication is a type of therapy that targets specific proteins on cancer cells.
Sotorasib is taken orally, meaning it is swallowed in the form of a pill.
3treatment schedule
The treatment is administered in cycles. Each cycle typically lasts a few weeks, with specific days designated for receiving the medications.
The healthcare team will provide a detailed schedule outlining the days and times for each medication administration.
4regular monitoring
Throughout the study, regular monitoring is conducted to assess the response to treatment and manage any side effects.
This includes routine blood tests, imaging scans, and physical examinations. The healthcare team will evaluate the effectiveness of the treatment and make any necessary adjustments.
5questionnaires and assessments
Participants are asked to complete quality of life questionnaires at various points during the study. These questionnaires help assess the impact of the treatment on daily life.
Geriatric assessments are also performed to evaluate overall health and well-being.
6end of treatment
The treatment continues until the study’s end date or until it is determined that the treatment is no longer beneficial.
A final assessment is conducted to evaluate the overall response to the treatment and to discuss any further steps or follow-up care.
Who Can Join the Study?
Must be at least 18 years old.
Must provide written consent to participate in the study.
Must have a life expectancy of more than 6 months.
Women of childbearing potential must agree to use birth control during the trial and for at least 6 months after stopping the trial treatments. Men who have sexual relationships with women of childbearing potential must agree to use birth control during the trial and for at least 3 months after stopping the trial treatments.
Must have a type of colorectal cancer that is advanced and cannot be removed by surgery, confirmed by a tissue sample.
Must agree to participate in additional biological studies, which include providing blood samples and a sample of the tumor.
Must be unable to undergo more aggressive chemotherapy treatments. This includes frail patients with a WHO Performance Status of 2, patients aged 70 to 75 with a WHO Performance Status of 1 or 2, and patients aged 75 or older with a WHO Performance Status of 0 to 2. WHO Performance Status is a measure of how well a person can perform ordinary tasks and carry out daily activities.
Must have a specific genetic mutation called KRAS G12C, confirmed by a test.
Must have a measurable tumor according to specific criteria used to evaluate cancer treatment response.
Must not have received any prior treatment for metastatic disease. Previous chemotherapy given after surgery is allowed.
Must have adequate organ function, which includes:
Hemoglobin level greater than 9 g/dl (a measure of red blood cells).
Absolute neutrophil count greater than 1500/mm3 (a type of white blood cell).
Platelet count greater than 80,000/mm3 (cells that help with blood clotting).
Creatinine clearance rate of at least 50 mL/min (a measure of kidney function).
ALT/AST levels no more than 5 times the upper limit of normal (liver enzymes).
Total bilirubin no more than 1.5 times the upper limit of normal (a substance made by the liver).
Must be able to understand and sign the consent form to participate in the study.
Who Cannot Join the Study?
Patients who have had another type of cancer in the past 5 years, except for skin cancer that is not melanoma or in situ cervical cancer (a very early form of cervical cancer).
Patients who have serious heart problems, such as heart failure or a recent heart attack.
Patients with uncontrolled high blood pressure.
Patients who have an active infection that requires treatment with antibiotics.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study drugs or similar drugs.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of drug or alcohol abuse within the past year.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate.
5-Fluorouracil is a type of chemotherapy drug used to treat various types of cancer, including colorectal cancer. It works by interfering with the cancer cells’ ability to grow and divide, which helps to slow down or stop the spread of the cancer.
Panitumumab is a medication that targets a specific protein on the surface of cancer cells called the epidermal growth factor receptor (EGFR). By blocking this protein, Panitumumab can help slow down or stop the growth of cancer cells. It is often used in combination with other cancer treatments.
Sotorasib is a medication designed to target a specific mutation in cancer cells known as KRAS G12C. This mutation is found in some types of cancer, including colorectal cancer. Sotorasib works by blocking the activity of the mutated protein, which can help to slow down or stop the growth of the cancer.
Colorectal Adenocarcinoma – Colorectal adenocarcinoma is a type of cancer that begins in the colon or rectum, which are parts of the large intestine. It originates from the glandular cells lining the colon and rectum, which produce mucus and other fluids. The disease typically starts as a benign polyp that can become cancerous over time. As it progresses, the cancer can invade deeper layers of the colon or rectum and may spread to nearby lymph nodes and other organs. Symptoms often include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others may metastasize to distant organs.
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