If you can answer 'yes' to these questions, then you may be eligible for this Amgen panitumumab research study.
A research study tests new treatments (study drugs) or new combinations of treatments to find out if the treatments are safe and effective for a particular disease.
You have metastatic colorectal cancer and your disease has not responded to your previous chemotherapy. You are being asked to take part in this study because researchers want to find out if either panitumumab (an investigational drug) or bevacizumab (a drug usually given for metastatic colorectal cancer) can help people with metastatic colorectal cancer when they receive it along with their regularly scheduled, standard second-line chemotherapy regimen (FOLFIRI) for metastatic colorectal cancer.
If you agree to take part in this research study, you will be one of approximately 200 patients that will be enrolled. The treatment portion of this study is expected to last approximately 6 months. Your involvement in this study is voluntary and will not change your originally agreed upon chemotherapy. If you decide not to participate or you withdraw from the study, there will be no loss of medical care for your illness or condition. Your participation in other clinical studies will not be affected if you do not participate or if you withdraw.
The study drug being tested is a monoclonal antibody called panitumumab. Antibodies are proteins that can be found circulating in the blood stream. Panitumumab is a manufactured antibody that is being developed by Amgen Inc. Panitumumab has been shown to turn off the activity of epidermal growth factor receptor (EGFR). This can stop the growth of cancer cells in laboratory tests. If the same is observed in people that receive panitumumab as part of their second-line chemotherapy, it is possible that their cancer will get better or resolve.
Panitumumab has been approved by the US FDA as a treatment for advanced colorectal cancer in patients whose cancer has progressed after standard chemotherapy. It is still considered experimental in the treatment setting for this study.
Participation in this study is voluntary and depends on your willingness to do the tests and on a doctor's assessments of whether it is appropriate for you to take part.
Before you can start the study, your study doctor or study staff will need to talk to you about the study. They will also provide to you an Informed Consent form to read and sign if you are willing to participate. After signing this form, your study doctor or study staff can schedule you for a screening visit.
The results from tests done during the screening visit will help your study doctor determine if you can participate in this study. This screening visit will occur about one month before you would start receiving treatment with the study drug. During your study visits, some of the following will be done:
At the screening visit, you will have a medical history taken, a complete physical examination, and blood samples (approximately 3 to 4 tablespoons) will be taken for laboratory testing. You will also have other procedures (such as a CT or MRI scan) to assess the extent of your disease.
If your doctor determines that you are eligible to participate in this study, and you are willing to do the tests, then you will be chosen at random (similar to tossing a coin) to receive either panitumumab by intravenous infusion (an injection directly into the vein) along with a standard chemotherapy regimen (FOLFIRI) or bevacizumab by intravenous infusion along with a standard chemotherapy regimen (FOLFIRI). You have an equal chance of being assigned to either therapy.
During the approximately 6-month treatment portion of this study, you will visit your doctor every 2 weeks to receive your therapy. At these visits, you will tell your study nurse or doctor how you feel and have the following tests: physical exam, weight, blood pressure, pulse, breathing, temperature, and blood tests. Every 8 weeks you will have a CT/MRI scan and blood tests to see if the treatment is having an effect on your cancer.
A follow-up visit will occur 1 month after the last time you receive the study drug, or within 1 month of when your cancer has progressed. After this visit, the study staff will call you, or you will return to the study center, about every 3 months, for approximately 1 year. During these follow-up calls/study visits, the study doctor or study staff will ask you questions about your health.
Your participation in this study should not result in any additional costs, other than those associated with the treatment of your cancer. All costs related to routine medical treatment of your cancer would be billed to you or to your insurance agent. You do not have to pay for panitumumab, study visits, or tests that are not part of your regular chemotherapy. However, due to the investigational nature of this research study, some insurance companies or government health care programs may limit their obligation to pay for experimental treatments and their consequences. In those cases, you may be responsible for payment of all charges related to the medical care you receive for treatment of your cancer. Additionally, you will not be paid any money for participating in this study.
Panitumumab may help your metastatic colorectal cancer, but there is no guarantee that being in this study will help you. Your metastatic colorectal cancer might not get any better or may even get worse while you are in this study. The drugs you receive may be harmful, and unknown side effects may occur, as well. However, information from this study might help researchers to develop new tests or medications to help others in the future.
Please ask your physician or staff at this office for additional details.
