Trial Information

Summary: Patients with breast cancer sought for research study.

UVA Health System, Cancer Center, seeks adults with breast cancer for a research study. The type of breast cancer being studied is estrogen-negative, progesterone-negative, and HER-2 negative breast cancer that has either returned or the cancer has spread to other parts of the body.

The purpose of this study is to find out what effects the drugs irinotecan and UCN-01 have on participants and breast cancer. Irinotecan is a commercially available drug and is currently used in treatments for colorectal cancer. It is considered experimental for this study of breast cancer. UCN-01 is an experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in breast or in any other cancer.

If you should decide to participate in the study, you will have your tumors measured (this may include such tests as CT scans, x-rays or bone scans), a physical examination which will include questions about your medical history and current medications, routine blood tests, and you will be given the choice to have the doctor take a small piece of your tumor (biopsy) to help learn more about your type of cancer. Prior to receiving treatment you will need to have a central catheter (tubing that is placed in a large vein in your chest) placed if you do not already have one. Irinotecan and UCN-01 will be given through this central catheter. You will receive treatment with irinotecan on days 1, 8, 15, and 22 and receive treatment with UCN-01 on days 2 and 23 of each 6 week cycle. These visits may also include physical exams and routine blood tests. During week 5 and week 6 of each cycle you will have routine blood tests only. At the end of each 6 week cycle you will have repeat scans or x-rays to see if your tumor is growing, shrinking, or staying the same size. You can continue to receive this treatment as long as your cancer has not grown and you are not having any bad side effects.

Treatments take place in the UVA Health System Cancer Center Clinic. After treatment ends, you may have a doctors visit scheduled over the next 30 days, which may include scans, x-rays, physical examination, and routine blood tests.

There is no compensation available for participants in this study.

Contact Information:
For more information please contact:
Patrick Morse
Phone: 434-924-9697
Email: pam5kh@virginia.edu
IRB-HSR #13296
Principal Investigator: Paula Fracasso, MD, PhD



www.healthsystem.virginia.edu/clinical_trials

If you would like to learn more about participating in this study, please send an e-mail message using the form below.