What happens if I decide to participate?
- Prior to undergoing any medical procedures to determine if you may participate in the study, you will review the informed consent form with the study staff and be asked to sign it, if you are still interested in participating. The informed consent form is meant to help you understand everything that will happen if you participate in the study, including the possible risks and benefits associated with your participation. You will receive study-related medical care and study medication at no cost.
- This study consists of three periods – a Screening period, a Treatment period and a Follow-up period that run one after the other.
- You will be expected to visit the study center for consultation appointment with your study doctor, follow-by trial treatment and procedures. Your travel to your study visits may be reimbursed once you are enrolled in the study.
- Once you are enrolled in the study, you will be asked to come to the clinic every 3 weeks during the treatment period. Each visit will last at least 4-6 hours depending on the assessments to be done and the treatment infusion duration.
- You will receive the first dose of study medication at first visit (Visit 1) and then every 3 weeks after that. The study drug or Avastin® will be given to you by intravenous infusion which means inserting a needle into your arm and slowly delivering the drug into your body. After the study drug or Avastin® infusion, you will also receive infusion with standard combination chemotherapy every 3 weeks, for up to 6 treatment cycles (up to 18 weeks).
- During the study visits, the study staff will discuss your current condition with you. In addition, blood and urine samples will be collected from you for laboratory testing.
- During the study, you can call your study staff at any time, to report problems or ask questions.
- You are required to return for unscheduled visits should your condition need immediate medical attention.
- Your participation is voluntary. You can change your mind and stop study medication at any time. Your study doctor can also stop study medication and remove you from the study at anytime (if it is in your best interest).