Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249977
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2005-11-02
Brief Title:
Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2009-10
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:
1 To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan
2 To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan
3 To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy
2 To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan
3 To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy
Detailed Description:
RATIONALE Many studies have tested the combination of cisplatin and irinotecan Side effects have been well described The two drugs are synergistic
The standard of care for colon cancer is the combination of 5-FU leucovorin and irinotecan Saltz regimen Recently oxaliplatin has been introduced for the treatment of colon cancer Combination of oxaliplatin with 5FU Folfox4 have shown comparable activity to the Saltz regimen Furthermore one author recently published on the triple combination of oxaliplatin 5FU and irinotecan with impressive clinical activity in colon cancer
There is some evidence that 5FU impairs DNA repair One of the putative resistance mechanism to topoisomerase I inhibitors is increased DNA repair We therefore hypothesize that inhibition of DNA repair by capecitabine may increase the activity of the combination of cisplatin and irinotecan
This study is open to all patients with solid tumor who have failed a line of chemotherapy
The standard of care for colon cancer is the combination of 5-FU leucovorin and irinotecan Saltz regimen Recently oxaliplatin has been introduced for the treatment of colon cancer Combination of oxaliplatin with 5FU Folfox4 have shown comparable activity to the Saltz regimen Furthermore one author recently published on the triple combination of oxaliplatin 5FU and irinotecan with impressive clinical activity in colon cancer
There is some evidence that 5FU impairs DNA repair One of the putative resistance mechanism to topoisomerase I inhibitors is increased DNA repair We therefore hypothesize that inhibition of DNA repair by capecitabine may increase the activity of the combination of cisplatin and irinotecan
This study is open to all patients with solid tumor who have failed a line of chemotherapy
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