A clinical study may be an option after pancreatic cancer surgery Ask if a clinical study is an option for you
What s inside? This brochure will help you learn about a clinical study called APACT. APACT stands for Adjuvant Pancreatic Adenocarcinoma Clinical Trial. The APACT study is open only to people whose pancreatic cancer has been removed with surgery. Is the APACT study right for me? Why might my doctor suggest more treatment after surgery? If you have early stage pancreatic cancer, surgery to try to remove or resect (ree-sekt) the whole tumor is an important step in your treatment plan. After you recover from surgery your doctor may offer additional treatment, called adjuvant therapy (A-joovunt THAYR-uh-pee). Adjuvant chemotherapy (kee-moh-thayr-uh-pee) uses medicines to try and kill any cancer cells that may remain in the body after surgery. A clinical study (or clinical trial) looks at potential new ways to treat disease or improve health. The goal of a clinical trial is to learn if a medicine works and is safe in certain people by studying those people under carefully managed conditions. People often think of clinical studies as a last resort. But joining a clinical study right after your tumor has been removed can be an important option to discuss with your doctor. A clinical study is one way to continue your cancer treatment after surgery. More treatment may be given after pancreatic surgery to try to keep the cancer from coming back. The APACT study aims to compare 2 therapies for people whose pancreatic cancer has been removed with surgery. A good time to talk to your doctor about adjuvant therapy is before you have your surgery. Ask your doctor to keep a sample of the tumor removed during your surgery for later use. Go to page 9 to learn why tumor samples are important. Clinical studies help doctors learn how therapies work. But it is not possible to know if the study therapy will work for you. 2 3
What is the APACT study? APACT is a worldwide clinical study for people with resectable pancreatic cancer. The APACT study is sponsored by Celgene. What is the goal of APACT? The APACT study compares 2 therapies for people whose pancreatic cancer has recently been removed: A chemotherapy called gemcitabine (jem-cy-tuh-been) Gemcitabine combined with another chemotherapy called nab -paclitaxel (nab-pak-li-tak-sel) nab-paclitaxel has not been approved for the treatment of pancreatic cancer after surgical resection. Its use in this study is investigational (in-ves-tih-gay-shuh-nul). The goal is to learn whether the combination therapy works better than the standard therapy or gemcitabine alone. In each group, researchers will be measuring How long people live without the cancer coming back How long people survive overall How safe it is to take the combination therapy Ask your doctor if joining the APACT study may be an option for you. Who can take part in the APACT study? You may be able to join the study if you Are 18 years of age or older Although there are no drugs currently FDA approved to treat pancreatic cancer after surgery, gemcitabine is a preferred drug that many doctors use. Now gemcitabine and nab-paclitaxel will be studied for use as adjuvant therapy. Have had, or will be having, surgery to remove a pancreatic tumor Can start treatment no later than 12 weeks after you have had a complete resection, or successful removal of your pancreatic cancer nab is a registered trademark of 4 Celgene Corporation. 5
How will the APACT study work? About 800 people who had surgery to remove their pancreatic tumors will be enrolled in APACT. Patients will be placed by chance into 1 of 2 groups. Each group will get a different treatment. Group 1 nab-paclitaxel + gemcitabine Group 2 gemcitabine You will have an equal chance of getting either of the 2 treatments. You and your doctor will know which treatment you are getting. How often are the treatments given? You will get weekly treatments for 3 weeks in a row, followed by 1 week of rest. This 4-week period is 1 treatment cycle. MON TUE WED THUR FRI SAT SUN 1 2 3 4 5 6 7 Treatment 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Rest You have surgery You are screened to see if you meet the study requirements You are placed by chance into 1 of 2 treatment groups Group 1 nab-paclitaxel + gemcitabine Group 2 gemcitabine Study team follows up Samples of your pancreatic tumor tissue will be saved. If you qualify for the study, you will be asked to give your informed consent before you join (see page 10). The study team will draw blood and request tissue samples from your surgeon. Treatment should start within 12 weeks after your surgery. You will get up to 6 cycles of treatment in all, depending on how well you tolerate the therapy. You or your doctor may choose to stop treatment at any time for any reason. This stage will last for up to 5 years. Your healthcare team will check up on you about every 3 months. 6 7
What should I expect during the APACT study? Along with providing your treatment, your healthcare team will Ask you to come in for regular checkups and blood tests Why are my tissue samples important? The APACT team will study the samples of tumor and normal tissue taken during your surgery. Working with tissue samples can help researchers learn who will respond to adjuvant pancreatic cancer treatment and why. Do periodic scans to see if your cancer returns Test your blood and tissue samples for their research They will also answer your questions, check how well you are managing with daily activities, and monitor you for any side effects you may have. Studying your tissue samples may help improve the diagnosis and treatment of pancreatic cancer in the future. The medicines used in APACT may affect normal cells along with cancer cells. This can cause side effects. Talk to your doctor about what side effects you may have. What costs are covered during the study? The study medicines and tests will be provided at no cost to you. Your health plan may cover costs for your routine medical care. You will not be paid for being in the study, but local laws may allow you to be paid back for travel expenses to and from the study center. Check with your insurer and your doctor about any costs related to the study. 8 9
What are some possible benefits of joining the APACT study? You will get adjuvant treatment that may help keep your cancer from coming back. However, it is never certain that the study therapy will work for you. Both study groups will receive active treatment. The study is designed to show how well the study drugs work for people whose pancreatic cancer has been removed with surgery. You will be part of a community of people helping to advance pancreatic cancer treatment. You will be taking an active role in your own care and may help to improve treatment for others. Before you join the study, you must give your informed consent. This means that you understand the possible benefits and risks of the study and agree to take part. Speak to your doctor about the possible benefits and risks of joining the APACT study. What are some possible risks of joining the APACT study? As in all clinical studies, the study treatment you receive may not work for you. The study medicines may not work as well for you as other available adjuvant therapies. Because chemotherapy can affect normal cells as well as cancer cells, you may have side effects from the study medicines. 10 11
The APACT clinical study is now enrolling patients after pancreatic surgery Learn more about the APACT study Call 1-866-743-9792 Visit www.theapactstudy.com E-mail theapactstudy@celgene.com Contact the study coordinator at the site listed below. Contact information: 2014 Celgene Corporation. 08/14