Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361244
Status:
TERMINATED
Last Update Posted:
2017-02-17
First Post:
2006-08-04
Brief Title:
SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase III Study of SU011248 Sutent in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Patients With Stage IV Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow 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 to determine the safety of SU011248 and the highest dose of this drug that can be given safely in combination with the chemotherapy drugs irinotecan and cetuximab Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors which may prevent tumors from growing any further Other studies have demonstrated the possibility that SU011248 may enhance the anti-tumor activity of other chemotherapy drugs such as irinotecan and cetuximab
Detailed Description:
Participants will be given a supply of SU011248 capsules to take at home in the morning for two weeks After taking the capsules for two weeks there will be a one-week rest period
Irinotecan will be administered on days 1 and 8 of every 21-day cycle as an intravenous infusion over 90 minutes Cetuximab will be administered intravenously on days 1 8 and 15 of every 21-day cycle The first treatment of cetuximab is a larger dose Beginning with the second treatment the participant will receive a smaller dose of cetuximab
Blood work will be repeated at every clinic visit on days 1 and 8 During cycle 1 blood will also be drawn on day 15
Tumor assessments will be repeated after 6 weeks 12 weeks and every 9 weeks thereafter and will be assessed by both a CT scan of the abdomen pelvis and a chest x-ray MUGA scans will be repeated every 4 cycles 12 weeks
Participants may continue to receive cycles of study treatment as long as their disease does not progress and they do not experience any serious side effects
Irinotecan will be administered on days 1 and 8 of every 21-day cycle as an intravenous infusion over 90 minutes Cetuximab will be administered intravenously on days 1 8 and 15 of every 21-day cycle The first treatment of cetuximab is a larger dose Beginning with the second treatment the participant will receive a smaller dose of cetuximab
Blood work will be repeated at every clinic visit on days 1 and 8 During cycle 1 blood will also be drawn on day 15
Tumor assessments will be repeated after 6 weeks 12 weeks and every 9 weeks thereafter and will be assessed by both a CT scan of the abdomen pelvis and a chest x-ray MUGA scans will be repeated every 4 cycles 12 weeks
Participants may continue to receive cycles of study treatment as long as their disease does not progress and they do not experience any serious side effects
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