Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127036
Status:
TERMINATED
Last Update Posted:
2017-03-23
First Post:
2005-08-03
Brief Title:
Trial for Microarray Analysis of Colon Cancer Outcome-A MACCO-A
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Multicenter Trial for Microarray Analysis of Colon Cancer Outcome-A MACCO-A
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
drug now on market
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 if the investigators can predict the sensitivity or resistance of colon cancer to the two available first line chemotherapy agents
Detailed Description:
Colorectal cancer is the third largest cause of cancer mortality in the United States The treatment of metastatic colorectal cancer is undergoing rapid improvement Currently there are two major chemotherapy regimens which can both be combined with anti-angiogenesis treatment These regimens are 5-Fluorouracil 5-FU irinotecan and 5-FU oxaliplatin Each therapy has roughly similar rates of response but it is unclear which specific therapy would benefit which patients The advent of genome wide expression analysis provides a tool to analyze these differences In the microarray analysis of colon cancer outcome trial sponsored by the National Institutes of Health NIH and Moffitt Cancer Center patients with newly diagnosed metastatic colon cancer are biopsied and samples are preserved in ribonucleic acid RNA later Patients are then randomized to either one of two state of the art regimens capecitabine irinotecan avastin bevacizumab or capecitabine oxaliplatin avastin Response to chemotherapy time to progression and overall survival are end points of this trial Once accrual of patients has been met the investigators will compare genome wide expression patterns for each group
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-0729 | OTHER | Pfizer | None |
| R21 CA10135 | OTHER_GRANT | None | None |
| XEL390 | OTHER | None | None |