Phase I Two-Dimensional Dose-Finding Study of Bortezomib in Combination With Gemcitabine/Doxorubicin in Metastatic Surgically Unresectable Urothelial Cancer or Other Solid Tumors
Gemcitabine and doxorubicin are designed to disrupt the growth of cancer cells, which causes
cancer cells to start to die. Bortezomib is designed to enter cells and interfere with a
substance found inside cells that is responsible for allowing cells to divide. This helps
to kill the tumor cells.
If you are found to be eligible to take part in this study, you will receive doses of the
study drugs based on when you join the study and how many people have started before you.
Two (2) participants will be entered into each dose level. Additional participants may be
added at a dose level if it is being well tolerated. The doses will increase until the
highest tolerable dose is found.
You will receive the 3 study drugs on the first day of each cycle. You will receive
gemcitabine for up to 90 minutes. Next you will receive doxorubicin over 15-30 minutes.
Bortezomib will be given last over 3-5 seconds. Every 14 days is considered a study "cycle."
While on study, you will have a complete physical exam before each dose of study drugs.
Blood (about 3 teaspoons) will be drawn to check bone marrow and kidney function each week
during the first month. The study doctor may decide to draw blood more often, if you are
having side effects to the study drugs. Your vital signs will be measured before you
receive the study drugs and 1 hour after the infusion.
At the end of Cycle 3, your tumor status will be re-evaluated. You will have CT scans and a
bone scan. Blood (about 2 tablespoons) will be drawn for routine tests.
You will be taken off study if the disease gets worse or intolerable side effects occur. If
you have stable disease, you may continue receiving therapy as long as your physician feel
you are benefiting.
Once you are off-study, you will receive a phone call every 6 months. You will be asked how
you are doing, the status of the disease, and if you have had other treatments.
This is an investigational study. Gemcitabine, doxorubicin, and bortezomib are all FDA
approved and commercially available. Their use in this study is considered investigational
because they have not been approved in patients with urothelial cancer. Up to 80 patients
will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Gemzar + Adriamycin given with Velcade
Prior to each 2 week cycle
Arlene Siefker-Radtke, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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