Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142467
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2005-08-31
Brief Title:
Gemcitabine Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase II Study of Gemcitabine Oxaliplatin in Combination With Bevacizumab Avastin in Patients With Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-03
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 test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects good or bad it has on patients with hepatocellular carcinoma
Detailed Description:
Treatment is given in cycles each cycle except for cycle 1 is 4 weeks long Cycle 1 is only 2 weeks long
During cycle one only bevacizumab will be given intravenously on day one Two weeks after receiving bevacizumab the patient will return to the clinic for treatment with all 3 study drugs
During cycle 2 and every cycle thereafter patients will receive bevacizumab intravenously on day one and day 15 gemcitabine intravenously on day 2 and day 16 oxaliplatin intravenously on day 2 and day 16
The following evaluations will be conducted on day 1 and day 15 of each cycle once every 2 weeks physical examination vital signs medical history blood tests and urine tests
Tumor measurements done by CT andor MRI will be repeated at the end of cycle 3 and every 2 cycles thereafter
Dynamic Contrast-Enhanced Magnetic Resonance Imaging DCE-MRI of the liver and Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment during cycle 1 and the Perfusion CT will be repeated at the end of cycle 3
Once study treatment is stopped the following evaluations will be performed physical exam vital signs blood work urine tests CT scan of chest abdomen and pelvis and tumor measurements by CT or MRI scans
Follow-up will consist of physical examinations and blood tests every 6 months
Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects
During cycle one only bevacizumab will be given intravenously on day one Two weeks after receiving bevacizumab the patient will return to the clinic for treatment with all 3 study drugs
During cycle 2 and every cycle thereafter patients will receive bevacizumab intravenously on day one and day 15 gemcitabine intravenously on day 2 and day 16 oxaliplatin intravenously on day 2 and day 16
The following evaluations will be conducted on day 1 and day 15 of each cycle once every 2 weeks physical examination vital signs medical history blood tests and urine tests
Tumor measurements done by CT andor MRI will be repeated at the end of cycle 3 and every 2 cycles thereafter
Dynamic Contrast-Enhanced Magnetic Resonance Imaging DCE-MRI of the liver and Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment during cycle 1 and the Perfusion CT will be repeated at the end of cycle 3
Once study treatment is stopped the following evaluations will be performed physical exam vital signs blood work urine tests CT scan of chest abdomen and pelvis and tumor measurements by CT or MRI scans
Follow-up will consist of physical examinations and blood tests every 6 months
Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects
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