Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479089
Status:
TERMINATED
Last Update Posted:
2015-11-01
First Post:
2007-05-24
Brief Title:
Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Weekly Docetaxel Taxotere Vs Weekly Docetaxel in Combination With ZD1839 Iressa As Consolidation Therapy For Metastatic Urothelial Cancer Following Maximal Response To Multi-Agent Chemotherapy
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted due to drug sponsor decision to not continue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
1 To compare the proportion of patients free from progression 9 months from the start of consolidation therapy with the combination of docetaxel and ZD1839 Iressa versus docetaxel alone For the purposes of this protocol consolidation therapy refers to treatment given at the time of maximal benefit from conventional front-line multi-agent chemotherapy
Secondary Objective
1 To compare time to progression TTP overall survival OS and cause-specific survival CSS in the two arms For completeness these will be reported both from the initiation of consolidation chemotherapy and from the completion of induction chemotherapy
1 To compare the proportion of patients free from progression 9 months from the start of consolidation therapy with the combination of docetaxel and ZD1839 Iressa versus docetaxel alone For the purposes of this protocol consolidation therapy refers to treatment given at the time of maximal benefit from conventional front-line multi-agent chemotherapy
Secondary Objective
1 To compare time to progression TTP overall survival OS and cause-specific survival CSS in the two arms For completeness these will be reported both from the initiation of consolidation chemotherapy and from the completion of induction chemotherapy
Detailed Description:
Docetaxel is a drug designed to help stop cancer cells from growing and dividing ZD1839 is also a drug designed to block cancer cells from growing and dividing
Before treatment starts you will have a complete physical exam Blood 2-3 tablespoons and urine tests will be taken as part of the usual evaluation of liver bone marrow blood clotting ability and kidney function A chest x-ray and ECG test to measure the electrical activity of the heart will be done You will have imaging studies such as a CT scan of the chest abdomen and pelvis and a bone scan to show the location of current tumors If needed an MRI scan of the brain will be done This evaluation is considered standard Women who are able to have children must have a negative blood pregnancy test Patients who have a history of invasive tumors in their bladder and who have not had a prior cystoscopy must have a screening cystoscopy with an EUA examination under anesthesia to check the extent of disease in their bladder An EUA of the bladder is a standard procedure for diagnosing and checking the status of bladder cancer
You will be randomly assigned as in the toss of a coin to one of two treatment groups Participants in one group will receive docetaxel alone Participants in the other group will receive docetaxel plus ZD1839 There is an equal chance of being assigned to either group Both you and the study doctor will know to which group you were assigned
Docetaxel will be given through a catheter a plastic tube placed in a large vein in the chest or arm The medication will be given over about thirty minutes one day each week for 4 weeks This will be followed by a 2 week break The 4 weeks of treatment and 2 weeks without treatment will be considered one course 6 weeks
Dexamethasone will be given to decrease the risk of having an allergic reaction to the docetaxel In the first cycle you will receive 3 doses of dexamethasone by mouth every 12 hours starting the night before the docetaxel infusion If you have no reaction the dexamethasone will be decreased in Course 2 to one dose twice on the day of therapy If there is no reaction in Course 2 the dexamethasone will be decreased further to 1 dose 1 hour before docetaxel treatment
ZD1839 is a medication taken by mouth every day without break Participants in the docetaxel plus ZD1839 group will take one ZD1839 tablet once a day at about the same time You can take ZD1839 with or without food If you forget to take a dose take the last missed dose as soon as you remember as long as it is at least 12 hours before the next dose is due If it is less than 12 hours until the next dose do not take the dose you have missed
During treatment you will have a weekly blood test 2-3 tablespoons to measure bone marrow function A physical exam and blood tests 2-3 tablespoons will be repeated before each cycle of treatment Imaging studies will be repeated at 9 months but may be performed sooner if you have symptoms that show your tumor may be getting worse These scans are considered part of standard routine follow-up
You will be on study as long as the tumor is not growing at a certain rate and there are no severe side effects Therapy will be stopped and you may be taken off study early if one or both of these things occur After 6 months patients can choose to continue therapy if they wish At the end of 4 cycles you will have the option to continue your assigned therapy as long as it is tolerated and there is no evidence that the disease is getting worse There is no maximum amount of time that you can receive treatment on this study
After the study is complete follow-up will be arranged at the discretion of your treating physician
This is an investigational study The FDA has authorized ZD1839 for research use only A total of 90 patients may take part in this study All will be enrolled at M D Anderson
Before treatment starts you will have a complete physical exam Blood 2-3 tablespoons and urine tests will be taken as part of the usual evaluation of liver bone marrow blood clotting ability and kidney function A chest x-ray and ECG test to measure the electrical activity of the heart will be done You will have imaging studies such as a CT scan of the chest abdomen and pelvis and a bone scan to show the location of current tumors If needed an MRI scan of the brain will be done This evaluation is considered standard Women who are able to have children must have a negative blood pregnancy test Patients who have a history of invasive tumors in their bladder and who have not had a prior cystoscopy must have a screening cystoscopy with an EUA examination under anesthesia to check the extent of disease in their bladder An EUA of the bladder is a standard procedure for diagnosing and checking the status of bladder cancer
You will be randomly assigned as in the toss of a coin to one of two treatment groups Participants in one group will receive docetaxel alone Participants in the other group will receive docetaxel plus ZD1839 There is an equal chance of being assigned to either group Both you and the study doctor will know to which group you were assigned
Docetaxel will be given through a catheter a plastic tube placed in a large vein in the chest or arm The medication will be given over about thirty minutes one day each week for 4 weeks This will be followed by a 2 week break The 4 weeks of treatment and 2 weeks without treatment will be considered one course 6 weeks
Dexamethasone will be given to decrease the risk of having an allergic reaction to the docetaxel In the first cycle you will receive 3 doses of dexamethasone by mouth every 12 hours starting the night before the docetaxel infusion If you have no reaction the dexamethasone will be decreased in Course 2 to one dose twice on the day of therapy If there is no reaction in Course 2 the dexamethasone will be decreased further to 1 dose 1 hour before docetaxel treatment
ZD1839 is a medication taken by mouth every day without break Participants in the docetaxel plus ZD1839 group will take one ZD1839 tablet once a day at about the same time You can take ZD1839 with or without food If you forget to take a dose take the last missed dose as soon as you remember as long as it is at least 12 hours before the next dose is due If it is less than 12 hours until the next dose do not take the dose you have missed
During treatment you will have a weekly blood test 2-3 tablespoons to measure bone marrow function A physical exam and blood tests 2-3 tablespoons will be repeated before each cycle of treatment Imaging studies will be repeated at 9 months but may be performed sooner if you have symptoms that show your tumor may be getting worse These scans are considered part of standard routine follow-up
You will be on study as long as the tumor is not growing at a certain rate and there are no severe side effects Therapy will be stopped and you may be taken off study early if one or both of these things occur After 6 months patients can choose to continue therapy if they wish At the end of 4 cycles you will have the option to continue your assigned therapy as long as it is tolerated and there is no evidence that the disease is getting worse There is no maximum amount of time that you can receive treatment on this study
After the study is complete follow-up will be arranged at the discretion of your treating physician
This is an investigational study The FDA has authorized ZD1839 for research use only A total of 90 patients may take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-2010-00595 | REGISTRY | NCI CTRP | None |