Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215982
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2005-09-19
Brief Title:
Study of Capecitabine With Irinotecan and Oxaliplatin Eloxatin in Advanced Colorectal Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin Eloxatin in Adult Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2010-09
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 find out how effective the new combination of the drugs Capecitabine Xeloda Oxaliplatin Eloxatin and Irinotecan Camptosar are against colon and rectal cancer All three of these drugs are approved by the Food and Drug Administration FDA for the treatment of colon or rectal cancer This however is the first time that these three drugs have been combined in this schedule for the treatment of colonrectal cancer
Detailed Description:
The primary objective of the study is to determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin Capecitabine and Irinotecan Secondary objectives are to determine the time to tumor progression and the toxicity and tolerability of Oxaliplatin Capecitabine and Irinotecan when administered in combination Study schema is as follows Cycles are 42 days long Patients will receive Oxaliplatin and Capecitabine on day 1 Capecitabine is an oral pill that will be taken for 14 days Patients return again on day 21 when they receive Irinotecan and Capecitabine Capecitabine again is taken for 14 days CT scans are performed at the end of the 6 week cycle to determine response
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 |
|---|---|---|---|
| XEL351 | OTHER | Roche | None |