Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165568
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2005-09-12
Brief Title:
Using Positron Emission Tomography to Evaluate the Effects of Bevacizumab on Intra-tumoral Pharmacokinetics of 5-fluorouracil in Metastatic Colorectal Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Using Positron Emission Tomography to Evaluate the Effects of Bevacizumab on Intra-tumoral Pharmacokinetics of 5-fluorouracil in Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2009-10
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 purpose of this study is to investigate whether bevacizumab helps 5-Fluorouracil 5-FU be delivered to the tumor more efficiently Bevacizumab has been shown to inhibit the formation of new blood vessels in tumors and works best in combination with drugs that require blood vessels for transportation Based on other experiments bevacizumab may work by improving the transportation of other drugs to the tumor
Detailed Description:
This is not a treatment study A treatment regimen has already been decided upon by the patient and doctor
At the screening visit for this trial the following will be performed a medical history physical examination CT scan to measure the amount and size of the tumors and a PET scan using glucose that has been attached to a small amount of radioactivity to determine how well the tumor takes up glucose
Patients will then be randomized into one of 2 treatment groups Group 1 will receive both 5-FU and bevacizumab on the first day of chemotherapy Group 2 will receive just 5-FU on the first day of chemotherapy
Patients will undergo a PET scan that uses water that has been attached to a small amount of radioactivity to measure how well the tumor takes up water prior to the 5-FU adminstration
After patients receive 5-Fu they will undergo a PET scan during which a small amount of 5-FU has been attached to a small amount of radioactivity to measure how well the tumor takes up 5-FU
At the screening visit for this trial the following will be performed a medical history physical examination CT scan to measure the amount and size of the tumors and a PET scan using glucose that has been attached to a small amount of radioactivity to determine how well the tumor takes up glucose
Patients will then be randomized into one of 2 treatment groups Group 1 will receive both 5-FU and bevacizumab on the first day of chemotherapy Group 2 will receive just 5-FU on the first day of chemotherapy
Patients will undergo a PET scan that uses water that has been attached to a small amount of radioactivity to measure how well the tumor takes up water prior to the 5-FU adminstration
After patients receive 5-Fu they will undergo a PET scan during which a small amount of 5-FU has been attached to a small amount of radioactivity to measure how well the tumor takes up 5-FU
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