Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106054
Status:
TERMINATED
Last Update Posted:
2010-08-27
First Post:
2005-03-18
Brief Title:
Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An Open-Label Multi-Center Phase II Trial of Neoadjuvant Irinotecan in Combination With Infusional 5-FU Leucovorin Folfiri Plus Bevacizumab in Patients With Unresectable Hepatic-Only Metastases of Colorectal Carcinoma
Status:
TERMINATED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After 1 year only 2 subjects enrolled and treated thus no meaningful efficacy analyses could be performed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study was terminated early due to low enrollment with only 2 subjects enrolled and treated after being open for enrollment for over a year Therefore no meaningful efficacy analyses could be performed
This trial is studying the effects good and bad of a combination of drugs Irinotecan in combination with infusional 5-FU leucovorin FOLFIFI plus Bevacizumab for cancer of the colon or rectum that has spread to the liver only and is currently not able to be removed by surgery All of the drugs that will be received in this research study have been approved in the United States for colorectal cancer that has spread to other areas of the body including the liver Another reason for doing this study is to see if the chemotherapy drugs FOLFIFI plus Bevacizumab can sufficiently decrease the size of the cancer in the liver so that any tumor remaining can be completely removed with surgery and if it can be removed whether doing so will prolong the time it takes the cancer to return andor prolong the life of these patients This trial is also looking at the genes of people who take part in this study to see if it is possible to find out characteristics that can help predict whose cancer will respond well or not so well and who will have more or less side effects to this chemotherapy
This trial is studying the effects good and bad of a combination of drugs Irinotecan in combination with infusional 5-FU leucovorin FOLFIFI plus Bevacizumab for cancer of the colon or rectum that has spread to the liver only and is currently not able to be removed by surgery All of the drugs that will be received in this research study have been approved in the United States for colorectal cancer that has spread to other areas of the body including the liver Another reason for doing this study is to see if the chemotherapy drugs FOLFIFI plus Bevacizumab can sufficiently decrease the size of the cancer in the liver so that any tumor remaining can be completely removed with surgery and if it can be removed whether doing so will prolong the time it takes the cancer to return andor prolong the life of these patients This trial is also looking at the genes of people who take part in this study to see if it is possible to find out characteristics that can help predict whose cancer will respond well or not so well and who will have more or less side effects to this chemotherapy
Detailed Description:
None
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