Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489593
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2007-06-20
Brief Title:
Olanzapine in Patients With Advanced Cancer and Weight Loss
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Dose-Finding Pilot Study of the Safety and Tolerability of Olanzapine in Patients With Advanced Cancer and Weight Loss
Status:
COMPLETED
Status Verified Date:
2015-01
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 the drug Olanzapine that can be given to patients with advanced cancer who are experiencing weight loss Researchers want to find out if Olanzapine can help decrease weight loss in patients who are experiencing it because of cancer How this drug affects performance status cancer-related symptoms and nutritional status in patients with advanced cancer will also be studied
Detailed Description:
Olanzapine is approved for the treatment of schizophrenia and bipolar disorder However patients who have received this drug for these reasons have also experienced weight gain Further studies in patients with cancer showed an improvement in appetite a decrease in nausea and a control of flushing feeling of warmth and sweating
If you are found to be eligible to take part in this study and before you receive your first dose of Olanzapine you will have routine blood tests about 2 teaspoons You will be asked a series of questions about your nutrition and how well you are able to perform daily activities These questions should take about 20 minutes to answer Your answers will help the study doctor decide if the study drug is helping you gain weight and if your weight gain is helping you feel better You will also have an electrocardiogram ECG - a test to measure the electrical activity of the heart Women who are able to have children must have a negative blood pregnancy test about 1 teaspoon
After the tests above are completed you will begin receiving Olanzapine The study drug will be taken by mouth once daily at bedtime for 28 days in a row Seven different doses of the drug are planned with 6 patients enrolled on each level The level you are assigned to will depend on when you are enrolled on this study All participants will begin taking the same strength of the study drug This will gradually increase about every 3 - 14 days until you reach the highest strength of the study drug for the dose level to which you are assigned
About every 2 weeks during this study for the first month and then about once a month thereafter you will have a physical exam including measurement of your vital signs blood pressure heart rate temperature and breathing rate and your medical history will be discussed You will also have routine blood tests about 2 teaspoons to check your general health
You will continue to receive the highest strength of the study drug for the dose level to which you are assigned for about 4 months unless you have intolerable side effects or if your weight continues to decrease The study doctor will decide if you should continue receiving Olanzapine after 4 months
This is an investigational study The FDA has approved Olanzapine for mental health diseases schizophrenia acute mania and bipolar disorder Its use in preventing weight loss is experimental Up to 57 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 and before you receive your first dose of Olanzapine you will have routine blood tests about 2 teaspoons You will be asked a series of questions about your nutrition and how well you are able to perform daily activities These questions should take about 20 minutes to answer Your answers will help the study doctor decide if the study drug is helping you gain weight and if your weight gain is helping you feel better You will also have an electrocardiogram ECG - a test to measure the electrical activity of the heart Women who are able to have children must have a negative blood pregnancy test about 1 teaspoon
After the tests above are completed you will begin receiving Olanzapine The study drug will be taken by mouth once daily at bedtime for 28 days in a row Seven different doses of the drug are planned with 6 patients enrolled on each level The level you are assigned to will depend on when you are enrolled on this study All participants will begin taking the same strength of the study drug This will gradually increase about every 3 - 14 days until you reach the highest strength of the study drug for the dose level to which you are assigned
About every 2 weeks during this study for the first month and then about once a month thereafter you will have a physical exam including measurement of your vital signs blood pressure heart rate temperature and breathing rate and your medical history will be discussed You will also have routine blood tests about 2 teaspoons to check your general health
You will continue to receive the highest strength of the study drug for the dose level to which you are assigned for about 4 months unless you have intolerable side effects or if your weight continues to decrease The study doctor will decide if you should continue receiving Olanzapine after 4 months
This is an investigational study The FDA has approved Olanzapine for mental health diseases schizophrenia acute mania and bipolar disorder Its use in preventing weight loss is experimental Up to 57 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?:
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