Valproic Acid and Bevacizumab in Patients With Advanced Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Valproic Acid Given in Combination With Bevacizumab in Patients With Advanced Cancer to Determine Safety and Tolerability|
- Highest tolerable dose of bevacizumab in combination with valproic acid [ Time Frame: 28 day cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Valproic Acid + Bevacizumab
Valproic acid administered at a dose of 5.3 mg/Kg/day on days 1 - 28. Depending on the calculated dose, patients will take capsules once or twice a day per mouth.
Bevacizumab administered at a dose of 2.5 mg/kg by vein every 2 weeks.
Drug: Valproic Acid
5.3 mg/kg by mouth daily x 28 days
Other Name: DepakeneDrug: Bevacizumab
2.5 mg/kg by vein over 90 minutes every 2 weeks
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Valproic acid works the same was way as bevacizumab and is also used in the treatment of seizures, migraine headaches, and mood disturbances in bipolar disorders.
If you are found to be eligible to take part in this study, you will receive the study drugs as an outpatient. You will receive bevacizumab by vein over 90 minutes (for the first infusion) once every 2 weeks. Once the study doctor determines that you are able to tolerate the drug, it will be given over 60 minutes for the second infusion and then over 30 minutes for further infusions. Valproic acid will be given by mouth (capsule(s)) each day for 28 days. You will take valproic acid once or twice a day depending on your dose. Every 28 days is considered 1 cycle.
You will have blood drawn (about 2 teaspoons) and urine collected for routine tests every cycle, about every 1-2 weeks, so that researchers can monitor the safety of the study drugs. Once every 8 weeks you will have tumor markers tested as part of the routine blood draw. You will have a physical exam once a cycle.
You will have either a CT or MRI scan of the tumor about every 8 weeks to check the status (whether it is growing or shrinking) of the cancer. If your doctor thinks other tests are necessary he/she will discuss those with you.
You will continue to receive bevacizumab and valproic acid as long as the disease is considered stable. You will receive up to 12 cycles of the study drug. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.
You will have an end-of-study visit 28 days after your last dose of bevacizumab. At this visit, you will have a complete physical exam, including measurement of your vital signs and blood pressure. You will have a neurological exam, and blood (about 2 teaspoons) will be drawn for routine and tumor marker tests. You will be asked about any medications you may be taking and whether you have had any side effects. You will also be asked how well you are able to perform daily activities.
This is an investigational study. Bevacizumab and valproic acid are both FDA approved and commercially available. Their use together in this study is investigational and authorized for use in research only. Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530907
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jennifer Wheler, MD||M.D. Anderson Cancer Center|