Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003254
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
1999-11-01
Brief Title:
SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-03
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Ethynyluracil may help fluorouracil kill more cancer cells by making tumor cells more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in treating patients with advanced colorectal cancer that has not responded to fluorouracil
PURPOSE Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in treating patients with advanced colorectal cancer that has not responded to fluorouracil
Detailed Description:
OBJECTIVES I Assess the confirmed response rate to fluorouracil 5-FU plus ethynyluracil 776C85 in patients with metastatic colorectal cancer that has been demonstrated to be resistant to 5-FU II Assess time to progression and survival in this group of patients III Assess the frequency and severity of toxicities associated with this treatment
OUTLINE Patients are stratified according to relapse while receiving adjuvant therapy relapse within 12 months of completing adjuvant therapy vs relapse while receiving adjuvant therapy Patients receive oral doses of ethynyluracil 776C85 and fluorouracil twice daily for 28 days followed by 1 week of rest Treatment continues every 5 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months the first year every 4 months the second year and every 6 months thereafter
PROJECTED ACCRUAL A total of 35-75 patients will be accrued for this study
OUTLINE Patients are stratified according to relapse while receiving adjuvant therapy relapse within 12 months of completing adjuvant therapy vs relapse while receiving adjuvant therapy Patients receive oral doses of ethynyluracil 776C85 and fluorouracil twice daily for 28 days followed by 1 week of rest Treatment continues every 5 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months the first year every 4 months the second year and every 6 months thereafter
PROJECTED ACCRUAL A total of 35-75 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9635 | OTHER | None | None |