Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307723
Status:
TERMINATED
Last Update Posted:
2009-08-10
First Post:
2006-03-24
Brief Title:
Study of Bevacizumab in Combination With 5-FU Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Tolerability and Efficacy Study of the Angiogenesis Inhibitor Bevacizumab in Combination With 5-Fluorouracil Oxaliplatin and External Beam Radiation Therapy Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 determine the safety of bevacizumab oxaliplatin 5-FU and gemcitabine in combination with external beam radiation therapyPhase I portion as well as to begin to collect information about whether this combination treatment is effective in treating patients with locally advanced pancreatic cancer Phase II portion
Detailed Description:
The combination of all three drugs and radiation treatment has never been given to people before therefore we are going to add just one additional drug at a time for safety reasons
The first group of participants 3-4 who enroll on the study will receive 5-FU radiation therapy with the added drug oxaliplatin this is called Regimen level 1 If these participants have few or easily manageable side effects then another group of participants will be enrolled and will receive 5-FU radiation oxaliplatin with the addition of bevacizumab this is called Regimen level 2
The combination of study drugs and radiation will last about 6 weeks this 6 week period is called a cycle 1
Regimen Level 1 will receive the following oxaliplatin intravenously on days 1 8 15 22 29 and 36 5-FU infused by a continuous infusion on days 1-5 8-12 15-19 22-26 29-33 and 36-38 radiation therapy Monday-Friday to complete on day 38
Regimen Level 2 will receive the following bevacizumab intravenously on days 1 15 and 29 oxaliplatin intravenously on days 1 8 15 22 29 and 36 5-FU infused by continuous infusion days 1-5 8-12 15-19 22-26 29-33 and 36-38 radiation therapy Monday-Friday to complete on day day 38
The following are tests and procedures that will be performed during cycle 1 physical examination blood work urine sample perfusion CT scan on day 12 for those participants enrolled at Massachusetts General Hospital
At the end of cycle 1 CT scans will be performed to evaluate the participants disease status before they receive combination gemcitabine and bevacizumab If the scans show the tumor has reduced in size and can be surgically removed then surgery will be scheduled and the patient will receive gemcitabine and bevacizumab about 4 weeks after the surgery If the scans show the tumor can not be removed the patient will receive the gemcitabinebevacizumab combination about 4 weeks after completing cycle 1
Cycles 2-5 consist of gemcitabine given intravenously on days 1 8 and 15 every 28 days bevacizumab given intravenously on days 1 and 15 every 28 days During cycles 2-5 the following tests and procedures will be performed physical examination including vital signs on day 1 and 15 of each cycle blood work on days 1 8 and 15 of each cycle a urine sample on day 1 of each cycle CT scans will be done every 2 cycles
It will take about 7 months to complete the study treatment longer for those who have surgery after Cycle 1
The first group of participants 3-4 who enroll on the study will receive 5-FU radiation therapy with the added drug oxaliplatin this is called Regimen level 1 If these participants have few or easily manageable side effects then another group of participants will be enrolled and will receive 5-FU radiation oxaliplatin with the addition of bevacizumab this is called Regimen level 2
The combination of study drugs and radiation will last about 6 weeks this 6 week period is called a cycle 1
Regimen Level 1 will receive the following oxaliplatin intravenously on days 1 8 15 22 29 and 36 5-FU infused by a continuous infusion on days 1-5 8-12 15-19 22-26 29-33 and 36-38 radiation therapy Monday-Friday to complete on day 38
Regimen Level 2 will receive the following bevacizumab intravenously on days 1 15 and 29 oxaliplatin intravenously on days 1 8 15 22 29 and 36 5-FU infused by continuous infusion days 1-5 8-12 15-19 22-26 29-33 and 36-38 radiation therapy Monday-Friday to complete on day day 38
The following are tests and procedures that will be performed during cycle 1 physical examination blood work urine sample perfusion CT scan on day 12 for those participants enrolled at Massachusetts General Hospital
At the end of cycle 1 CT scans will be performed to evaluate the participants disease status before they receive combination gemcitabine and bevacizumab If the scans show the tumor has reduced in size and can be surgically removed then surgery will be scheduled and the patient will receive gemcitabine and bevacizumab about 4 weeks after the surgery If the scans show the tumor can not be removed the patient will receive the gemcitabinebevacizumab combination about 4 weeks after completing cycle 1
Cycles 2-5 consist of gemcitabine given intravenously on days 1 8 and 15 every 28 days bevacizumab given intravenously on days 1 and 15 every 28 days During cycles 2-5 the following tests and procedures will be performed physical examination including vital signs on day 1 and 15 of each cycle blood work on days 1 8 and 15 of each cycle a urine sample on day 1 of each cycle CT scans will be done every 2 cycles
It will take about 7 months to complete the study treatment longer for those who have surgery after Cycle 1
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