Last updated on June 2017

Ramucirumab for Advanced Pre-Treated Biliary Cancers


Brief description of study

The goal of this clinical research study is to learn if ramucirumab can help to control biliary cancer. The safety of this drug will also be studied.

Detailed Study Description

Study Drug Administration: If you are found to be eligible to take part in this study, you will receive ramucirumab by vein over about 60 minutes on Day 1 of each 14-day study cycle. Study visits: On or before Day 1 of each cycle: - You will have a physical exam. - Blood (about 2 tablespoons) and urine will be collected for routine tests. On Day 1 of every 2 cycles, blood (about 1 tablespoon) will be drawn for tumor marker testing. Tumor markers may be related to the status of the disease. On Day 1 of Cycle 4 and then every 4 cycles after that (Cycles 8, 12, 16, and so on), you will have a CT scan or MRI to check the status of the disease. Length of Treatment: You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after follow-up. Follow-Up Visits: Within 10 days after your last dose of study drug: - You will have a physical exam. - Blood (about 2 tablespoons) and urine will be collected for routine tests. - If you have not had one in the last 4 weeks, you will have a CT scan or MRI to check the status of the disease. About 30 days after your last dose of study drug, if you have not had one in the last 4 weeks, you will have a CT scan or MRI to check the status of the disease. If you are not able to come to MD Anderson for the Day 30 follow-up visit, you will be contacted by phone and asked how you are feeling. Every 3 months after the 30-day visit, you will be contacted by phone or your medical record will be checked to monitor your health. This is an investigational study. Ramucirumab is FDA approved and commercially available for the treatment of colorectal cancer, gastric cancer, and non-small cell lung cancer (NSCLC). It is considered investigational to use ramucirumab to treat biliary cancer. The study doctor can explain how the study drug is designed to work. Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02520141

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Rachna Shroff, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
  Connect »