Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509860
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2007-07-30
Brief Title:
Irinotecan Camptosar in Patients With Advanced Sarcomas
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Irinotecan Camptosar in Patients With Advanced Sarcomas
Status:
COMPLETED
Status Verified Date:
2012-12
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 efficacy of the topoisomerase I topo I inhibitor irinotecan delivered via a low-dose protracted schedule to patients with advanced sarcoma
2 To determine the toxicity profile of irinotecan using a protracted schedule in this pretreated patient population
1 To determine the efficacy of the topoisomerase I topo I inhibitor irinotecan delivered via a low-dose protracted schedule to patients with advanced sarcoma
2 To determine the toxicity profile of irinotecan using a protracted schedule in this pretreated patient population
Detailed Description:
Irinotecan is a chemotherapy drug that fights cancer by interfering with the cancer cells ability to divide and grow
Before treatment starts you will be asked questions about your health and have a complete physical exam You will have an electrocardiogram ECG - a test that measures the electrical activity of the heart You will have computed tomography CT scans and x-rays to check on the status of the disease If your doctor feels it is necessary you may also have a magnetic resonance imaging MRI Women who are able to have children must have a negative blood or urine pregnancy test
During treatment you will receive irinotecan by vein over one hour once a day for 5 days in a row This will be followed by 2 days of no study drug treatment then 5 more days of treatment with irinotecan This 12-day period will be followed by 9 days of rest no study drug This 21-day period is called a cycle of therapy You will continue to receive treatment cycles repeated as long as the disease does not get worse or until maximal shrinkage of the cancer Treatment may be taken on an outpatient basis
During treatment you will have blood collected 1-2 teaspoons once a week for routine tests At least once every cycle of treatment 3 weeks you will have a physical exam and be asked questions about you health
After the first 2 cycles the disease will be re-evaluated You will have blood tests 1-2 teaspoons x-rays and CT scans If your doctor feels it is necessary you may also have a MRI This re-evaluation will be repeated every 4 cycles
If the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
Your doctor may choose to follow up with long-term exams at hisher discretion
This is an investigational study Irinotecan is FDA approved and is commercially available Up to 60 participants will take part in this study All will be enrolled at M D Anderson
Before treatment starts you will be asked questions about your health and have a complete physical exam You will have an electrocardiogram ECG - a test that measures the electrical activity of the heart You will have computed tomography CT scans and x-rays to check on the status of the disease If your doctor feels it is necessary you may also have a magnetic resonance imaging MRI Women who are able to have children must have a negative blood or urine pregnancy test
During treatment you will receive irinotecan by vein over one hour once a day for 5 days in a row This will be followed by 2 days of no study drug treatment then 5 more days of treatment with irinotecan This 12-day period will be followed by 9 days of rest no study drug This 21-day period is called a cycle of therapy You will continue to receive treatment cycles repeated as long as the disease does not get worse or until maximal shrinkage of the cancer Treatment may be taken on an outpatient basis
During treatment you will have blood collected 1-2 teaspoons once a week for routine tests At least once every cycle of treatment 3 weeks you will have a physical exam and be asked questions about you health
After the first 2 cycles the disease will be re-evaluated You will have blood tests 1-2 teaspoons x-rays and CT scans If your doctor feels it is necessary you may also have a MRI This re-evaluation will be repeated every 4 cycles
If the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
Your doctor may choose to follow up with long-term exams at hisher discretion
This is an investigational study Irinotecan is FDA approved and is commercially available Up to 60 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