Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479128
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2007-05-24
Brief Title:
Bortezomib with GemcitabineDoxorubicin in Patients with Urothelial Cancer and Other Solid Tumors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Two-Dimensional Dose-Finding Study of Bortezomib in Combination with GemcitabineDoxorubicin in Metastatic Surgically Unresectable Urothelial Cancer or Other Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of Gemzar gemcitabine and Adriamycin doxorubicin that can be given together with Velcade bortezomib in patients with urothelial cancer or other solid tumors
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-00596 | REGISTRY | NCI CTRP | None |