Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354523
Status:
TERMINATED
Last Update Posted:
2014-12-17
First Post:
2006-07-18
Brief Title:
Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Study to Evaluate the Efficacy and Toxicity of Imatinib Mesylate in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed following Phase I portion insufficient activity to continue to Phase II
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
Primary objectives
To determine the maximum tolerated doses MTD for the combination of imatinib mesylate capecitabine and dacarbazine in patients with solid tumors
To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma
To determine the tolerability toxicity of this regimen
Secondary objectives
To determine the median overall survival OS and time to progression TTP for patients treated with this combination
Primary objectives
To determine the maximum tolerated doses MTD for the combination of imatinib mesylate capecitabine and dacarbazine in patients with solid tumors
To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma
To determine the tolerability toxicity of this regimen
Secondary objectives
To determine the median overall survival OS and time to progression TTP for patients treated with this combination
Detailed Description:
Phase I
Imatinib mesylate is a drug that binds to certain proteins on the tumor cells which may prevent the cells from growing Capecitabine and dacarbazine are drugs that interfere with the growth of cancer cells
If you are found to be eligible to take part in this study you will begin treatment with imatinib mesylate capecitabine and dacarbazine
You will come to M D Anderson at least once every three weeks 21 days for treatment Each 21-day period of treatment is called a cycle of therapy You will receive at least 3 cycles of therapy 9 weeks unless side effects are severe or the cancer grows very quickly
The first group of study participants will receive lower doses of imatinib mesylate capecitabine and dacarbazine If these doses appear to be safe the next group of participants will receive higher doses This will continue until the highest doses that may be safely given are found
You will take imatinib mesylate capsules by mouth once a day on Days 1-21 of each cycle Imatinib mesylate should be taken with a meal with a large glass of water
You will take capecitabine tablets by mouth twice a day on Days 1-14 of each cycle You should take each dose of capecitabine within 30 minutes after eating a meal It is important to take the tablets together with water and not fruit juices Each dose of capecitabine should be about 12 hours apart for example after breakfast and after your evening meal
You will have a small tube central venous line inserted into a large vein under the skin of the chest or through a vein in the arm to receive dacarbazine Dacarbazine will be given over 1 hour on Days 1-3 of each cycle
During the first cycle of therapy blood about 2 ½ teaspoons will be collected once a week for routine tests Before each new cycle of therapy you will have a complete physical exam and urine and blood about 2 ½ teaspoons will be collected for routine tests You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced You will also have either CT scans or a MRI of the tumors every 9 weeks and at the end of the study Additional tests may be done during the study if your doctor feels it is necessary for your care All tests before each new cycle of treatment and when treatment stops must be done at M D Anderson
You should always tell the study doctor if you are taking any other medication if you have seen another doctor if you have received new treatments or if there is any change in the way you are feeling since the last visit If you are seeing another doctors you should inform these doctors that you are currently in this study Have the doctor contact the study doctor to discuss any other necessary treatments
If you experience severe side effects treatment may be delayed stopped or you may receive smaller doses of the drugs You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects If this happens you will be taken off the study and your doctor will discuss other treatment options with you
When you stop taking part in the study you will have blood about 3 teaspoons collected for routine tests You will have a physical exam and either a CT scan or a MRI to check on the status of the disease You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing
This is an investigational study The drugs dacarbazine imatinib mesylate and capecitabine are FDA approved and commercially available for treating certain forms of cancer Up to 24 participants will take part in this study All will be enrolled at M D Anderson
Phase II
Imatinib mesylate is a drug that binds to certain proteins on the tumor cells which may prevent the cells from growing Capecitabine and dacarbazine are drugs that interfere with the growth of cancer cells
If you are found to be eligible to take part in this study you will begin treatment with imatinib mesylate capecitabine and dacarbazine
You will come to M D Anderson at least once every three weeks 21 days for treatment Each 21-day period of treatment is called a cycle of therapy You will receive at least 3 cycles of therapy 9 weeks unless side effects are severe or the cancer grows very quickly
You will take imatinib mesylate capsules by mouth once a day on Days 1-21 of each cycle Imatinib mesylate should be taken with a meal with a large glass of water
You will take capecitabine tablets by mouth twice a day on Days 1-14 of each cycle You should take each dose of capecitabine within 30 minutes after eating a meal It is important to take the tablets together with water and not fruit juices Each dose of capecitabine should be about 12 hours apart for example after breakfast and after your evening meal
You will have a small tube central venous line inserted into a large vein under the skin of the chest or through a vein in the arm to receive dacarbazine Dacarbazine will be given over 1 hour on Days 1-3 of each cycle
During the first cycle of therapy blood about 2 ½ teaspoons will be collected once a week for routine tests Before each new cycle of therapy you will have a complete physical exam and urine and blood about 2 ½ teaspoons will be collected for routine tests You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced You will also have either CT scans or a MRI of the tumors every 9 weeks and at the end of the study Additional tests may be done during the study if your doctor feels it is necessary for your care All tests before each new cycle of treatment and when treatment stops must be done at M D Anderson
You should always tell the study doctor if you are taking any other medication if you have seen another doctor if you have received new treatments or if there is any change in the way you are feeling since the last visit If you are seeing another doctors you should inform these doctors that you are currently in this study Have the doctor contact the study doctor to discuss any other necessary treatments
If you experience severe side effects treatment may be delayed stopped or you may receive smaller doses of the drugs You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects If this happens you will be taken off the study and your doctor will discuss other treatment options with you
When you stop taking part in the study you will have blood about 3 teaspoons collected for routine tests You will have a physical exam and either a CT scan or a MRI to check on the status of the disease You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing
This is an investigational study The drugs dacarbazine imatinib mesylate and capecitabine are FDA approved and commercially available for treating other forms of cancer They are not approved for the treatment of medullary thyroid carcinoma Up to 28 participants will take part in this study All will be enrolled at M D Anderson
Imatinib mesylate is a drug that binds to certain proteins on the tumor cells which may prevent the cells from growing Capecitabine and dacarbazine are drugs that interfere with the growth of cancer cells
If you are found to be eligible to take part in this study you will begin treatment with imatinib mesylate capecitabine and dacarbazine
You will come to M D Anderson at least once every three weeks 21 days for treatment Each 21-day period of treatment is called a cycle of therapy You will receive at least 3 cycles of therapy 9 weeks unless side effects are severe or the cancer grows very quickly
The first group of study participants will receive lower doses of imatinib mesylate capecitabine and dacarbazine If these doses appear to be safe the next group of participants will receive higher doses This will continue until the highest doses that may be safely given are found
You will take imatinib mesylate capsules by mouth once a day on Days 1-21 of each cycle Imatinib mesylate should be taken with a meal with a large glass of water
You will take capecitabine tablets by mouth twice a day on Days 1-14 of each cycle You should take each dose of capecitabine within 30 minutes after eating a meal It is important to take the tablets together with water and not fruit juices Each dose of capecitabine should be about 12 hours apart for example after breakfast and after your evening meal
You will have a small tube central venous line inserted into a large vein under the skin of the chest or through a vein in the arm to receive dacarbazine Dacarbazine will be given over 1 hour on Days 1-3 of each cycle
During the first cycle of therapy blood about 2 ½ teaspoons will be collected once a week for routine tests Before each new cycle of therapy you will have a complete physical exam and urine and blood about 2 ½ teaspoons will be collected for routine tests You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced You will also have either CT scans or a MRI of the tumors every 9 weeks and at the end of the study Additional tests may be done during the study if your doctor feels it is necessary for your care All tests before each new cycle of treatment and when treatment stops must be done at M D Anderson
You should always tell the study doctor if you are taking any other medication if you have seen another doctor if you have received new treatments or if there is any change in the way you are feeling since the last visit If you are seeing another doctors you should inform these doctors that you are currently in this study Have the doctor contact the study doctor to discuss any other necessary treatments
If you experience severe side effects treatment may be delayed stopped or you may receive smaller doses of the drugs You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects If this happens you will be taken off the study and your doctor will discuss other treatment options with you
When you stop taking part in the study you will have blood about 3 teaspoons collected for routine tests You will have a physical exam and either a CT scan or a MRI to check on the status of the disease You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing
This is an investigational study The drugs dacarbazine imatinib mesylate and capecitabine are FDA approved and commercially available for treating certain forms of cancer Up to 24 participants will take part in this study All will be enrolled at M D Anderson
Phase II
Imatinib mesylate is a drug that binds to certain proteins on the tumor cells which may prevent the cells from growing Capecitabine and dacarbazine are drugs that interfere with the growth of cancer cells
If you are found to be eligible to take part in this study you will begin treatment with imatinib mesylate capecitabine and dacarbazine
You will come to M D Anderson at least once every three weeks 21 days for treatment Each 21-day period of treatment is called a cycle of therapy You will receive at least 3 cycles of therapy 9 weeks unless side effects are severe or the cancer grows very quickly
You will take imatinib mesylate capsules by mouth once a day on Days 1-21 of each cycle Imatinib mesylate should be taken with a meal with a large glass of water
You will take capecitabine tablets by mouth twice a day on Days 1-14 of each cycle You should take each dose of capecitabine within 30 minutes after eating a meal It is important to take the tablets together with water and not fruit juices Each dose of capecitabine should be about 12 hours apart for example after breakfast and after your evening meal
You will have a small tube central venous line inserted into a large vein under the skin of the chest or through a vein in the arm to receive dacarbazine Dacarbazine will be given over 1 hour on Days 1-3 of each cycle
During the first cycle of therapy blood about 2 ½ teaspoons will be collected once a week for routine tests Before each new cycle of therapy you will have a complete physical exam and urine and blood about 2 ½ teaspoons will be collected for routine tests You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced You will also have either CT scans or a MRI of the tumors every 9 weeks and at the end of the study Additional tests may be done during the study if your doctor feels it is necessary for your care All tests before each new cycle of treatment and when treatment stops must be done at M D Anderson
You should always tell the study doctor if you are taking any other medication if you have seen another doctor if you have received new treatments or if there is any change in the way you are feeling since the last visit If you are seeing another doctors you should inform these doctors that you are currently in this study Have the doctor contact the study doctor to discuss any other necessary treatments
If you experience severe side effects treatment may be delayed stopped or you may receive smaller doses of the drugs You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects If this happens you will be taken off the study and your doctor will discuss other treatment options with you
When you stop taking part in the study you will have blood about 3 teaspoons collected for routine tests You will have a physical exam and either a CT scan or a MRI to check on the status of the disease You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing
This is an investigational study The drugs dacarbazine imatinib mesylate and capecitabine are FDA approved and commercially available for treating other forms of cancer They are not approved for the treatment of medullary thyroid carcinoma Up to 28 participants will 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