Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353145
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2006-07-13
Brief Title:
Gemox as First and Second Line Therapy in Unknown Primary Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study to Evaluate the Efficacy and Toxicity of Oxaliplatin in Combination With Gemcitabine as First and Second Line Therapy in Unknown Primary Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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:
Primary objectives
1 To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine GEMOX as first line and second line therapy in unknown primary cancer UPC
2 To determine the tolerability toxicity of this regimen in this patient population
Secondary objectives
1 To determine the median overall survival OS and time to progression TTP for patients treated with this combination
2 To determine the impact of this combination on quality of life QOL in this patient population
1 To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine GEMOX as first line and second line therapy in unknown primary cancer UPC
2 To determine the tolerability toxicity of this regimen in this patient population
Secondary objectives
1 To determine the median overall survival OS and time to progression TTP for patients treated with this combination
2 To determine the impact of this combination on quality of life QOL in this patient population
Detailed Description:
Oxaliplatin is a chemotherapy drug that causes the death of cancer cells and other actively dividing cells by interfering with Deoxyribonucleic acid DNA function Gemcitabine prevents cells from making DNA and Ribonucleic acid RNA that are necessary for cell growth thus disrupting the growth of the cancer cells which causes the cancer cells to start to die
After the screening portion of the study if you are eligible to begin study treatment you will come to M D Anderson at least every two weeks 14 days for treatment Each 14-day period of treatment is called a cycle of therapy You will receive at least 3 cycles of therapy 6 weeks unless side effects become intolerable or the disease progresses
When you begin treatment 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 for administration of oxaliplatin and gemcitabine The central venous line will remain in place the entire time you are taking part in this study Both drugs must be given at M D Anderson On Day 1 of each cycle you will receive gemcitabine injected into a vein over 2 hours On Day 2 of each cycle you will receive oxaliplatin injected into a vein over 2 hours This drug schedule will be repeated every 2 weeks
You will first be asked to fill out several questionnaires that deal with your quality of life These will help the researchers understand how the study drugs affect your quality of life including your pain level fatigue tiredness level appetite and ability to perform everyday tasks in spite of whether there is any shrinkage of the tumor It will take about 30 minutes to an hour to complete the forms You will also be asked to complete a questionnaire one time only that asks questions about why you decided to take part in this study
During the first cycle of therapy blood about 2 12 teaspoons will be collected once a week for routine tests Before each new cycle of therapy you will have a complete physical exam urine will be collected and blood will be drawn about 2 ½ teaspoons 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 computed tomography CT scans or an Magnetic resonance imaging MRI of the tumors every 6 weeks and at the end of the study
All tests before each new cycle of treatment and when treatment stops must be done at M D Anderson Extra tests may be done during the study if your doctor feels it is necessary for your care Every 6 weeks for as long as you are on study you will also be asked to fill out the questionnaires that help study doctors understand your quality of life It will take about 30 minutes to an hour to complete the forms
If you experience intolerable side effects treatment may be delayed stopped or you may receive smaller doses of the treatment You may continue to receive treatment on this study unless 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 for any reason you will have blood about 3 teaspoons collected for final routine tests You will have one more physical exam and either a CT scan or a MRI to check on the status of the disease You will also be asked once more to fill out the questionnaires that help assess your quality of life It will take about 30 minutes to an hour to complete the forms
Once you stop receiving study treatment you will be contacted by phone every three months for the rest of your life to check on how you are doing and any symptoms you may be experiencing
This is an investigational study Oxaliplatin is FDA approved for treatment of advanced cancer of the colon or rectum and gemcitabine is FDA approved for the treatment of advanced cancer of the pancreas However the combination of the two drugs for treatment of cancers with unknown primaries is still considered investigational Up to 81 people will take part in this study All will be enrolled at M D Anderson
After the screening portion of the study if you are eligible to begin study treatment you will come to M D Anderson at least every two weeks 14 days for treatment Each 14-day period of treatment is called a cycle of therapy You will receive at least 3 cycles of therapy 6 weeks unless side effects become intolerable or the disease progresses
When you begin treatment 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 for administration of oxaliplatin and gemcitabine The central venous line will remain in place the entire time you are taking part in this study Both drugs must be given at M D Anderson On Day 1 of each cycle you will receive gemcitabine injected into a vein over 2 hours On Day 2 of each cycle you will receive oxaliplatin injected into a vein over 2 hours This drug schedule will be repeated every 2 weeks
You will first be asked to fill out several questionnaires that deal with your quality of life These will help the researchers understand how the study drugs affect your quality of life including your pain level fatigue tiredness level appetite and ability to perform everyday tasks in spite of whether there is any shrinkage of the tumor It will take about 30 minutes to an hour to complete the forms You will also be asked to complete a questionnaire one time only that asks questions about why you decided to take part in this study
During the first cycle of therapy blood about 2 12 teaspoons will be collected once a week for routine tests Before each new cycle of therapy you will have a complete physical exam urine will be collected and blood will be drawn about 2 ½ teaspoons 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 computed tomography CT scans or an Magnetic resonance imaging MRI of the tumors every 6 weeks and at the end of the study
All tests before each new cycle of treatment and when treatment stops must be done at M D Anderson Extra tests may be done during the study if your doctor feels it is necessary for your care Every 6 weeks for as long as you are on study you will also be asked to fill out the questionnaires that help study doctors understand your quality of life It will take about 30 minutes to an hour to complete the forms
If you experience intolerable side effects treatment may be delayed stopped or you may receive smaller doses of the treatment You may continue to receive treatment on this study unless 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 for any reason you will have blood about 3 teaspoons collected for final routine tests You will have one more physical exam and either a CT scan or a MRI to check on the status of the disease You will also be asked once more to fill out the questionnaires that help assess your quality of life It will take about 30 minutes to an hour to complete the forms
Once you stop receiving study treatment you will be contacted by phone every three months for the rest of your life to check on how you are doing and any symptoms you may be experiencing
This is an investigational study Oxaliplatin is FDA approved for treatment of advanced cancer of the colon or rectum and gemcitabine is FDA approved for the treatment of advanced cancer of the pancreas However the combination of the two drugs for treatment of cancers with unknown primaries is still considered investigational Up to 81 people 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