Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063960
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2003-07-08
Brief Title:
Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic Liver Metastases From Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial Of Toxicity Assessment In Two Cohorts Of Patients Resection Alone Or Ablation With Or Without Resection Of Hepatic Metastases From Colorectal Cancer Treated With Adjuvant Hepatic Arterial Infusion HAI FUDR Plus Systemic CPT-11
Status:
COMPLETED
Status Verified Date:
2016-07
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 such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery
PURPOSE Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic liver metastases from colorectal cancer
PURPOSE Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Determine the toxicity of hepatic arterial infusion with floxuridine and systemic irinotecan adjuvant to liver metastases resection or ablation with or without resection in patients with hepatic metastases secondary to colorectal cancer
Determine the overall survival of patients treated with this regimen
Determine the time to any hepatic recurrence or progression in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to prior therapy liver metastases resection only vs ablation with or without resection
Within 4-8 weeks after prior resection or ablation patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15 Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity
Patients are followed every 3 months for 2 years
Determine the toxicity of hepatic arterial infusion with floxuridine and systemic irinotecan adjuvant to liver metastases resection or ablation with or without resection in patients with hepatic metastases secondary to colorectal cancer
Determine the overall survival of patients treated with this regimen
Determine the time to any hepatic recurrence or progression in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to prior therapy liver metastases resection only vs ablation with or without resection
Within 4-8 weeks after prior resection or ablation patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15 Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity
Patients are followed every 3 months for 2 years
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 |
|---|---|---|---|
| ACOSOG-Z05032 | None | None | None |
| CDR0000305857 | REGISTRY | NCI Physician Data Query | None |