Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase I Two-Dimensional Dose-Finding Study of Bortezomib in Combination With Gemcitabine/Doxorubicin in Metastatic Surgically Unresectable Urothelial Cancer or Other Solid Tumors|
- Maximum Tolerated Dose (MTD) of Gemzar + Adriamycin Given with Velcade [ Time Frame: Prior to each 2 week cycle ]
- Response of Gemzar + Adriamycin Given with Velcade [ Time Frame: 42 days ]
Participants be assessed for response on the basis of conventional response criteria for urothelial cancer.
Tumor status re-evaluated by CT scans and a bone scan.
|Actual Study Start Date:||September 2006|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: Bortezomib + Gemcitabine + Doxorubicin
Starting dose of Bortezomib 0.8 mg/m^2 IV Over 3-5 Seconds. Starting dose of Gemcitabine 225 mg/m^2 IV Up to 90 Minutes. Starting dose of Doxorubicin 12.5 mg/m^2 IV Over 15-30 minutes.
Starting dose: 0.8 mg/m^2 IV Over 3-5 Seconds
Other Names:Drug: Gemcitabine
Starting dose: 225 mg/m^2 IV Up to 90 Minutes
Other Names:Drug: Doxorubicin
Starting dose: 12.5 mg/m^2 IV Over 15-30 minutes
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479128
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Arlene Siefker-Radtke, MD||M.D. Anderson Cancer Center|