Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003753
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Floxuridine Dexamethasone and Irinotecan After Surgery in Treating Patients With Liver Metastases From Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I-II Study of Hepatic Arterial Therapy Via Pump Protocol D97-063 With Floxuridine FUDR and Dexamethasone DEX in Combination With Intravenous Irinotecan as Adjuvant Treatment After Resection of Hepatic Metastases From Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 dexamethasone 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 irinotecan combined with hepatic arterial infusion with floxuridine and dexamethasone after surgery in treating patients who have liver metastases from colorectal cancer
PURPOSE Phase II trial to study the effectiveness of irinotecan combined with hepatic arterial infusion with floxuridine and dexamethasone after surgery in treating patients who have liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of hepatic arterial infusion of floxuridine FUDR and dexamethasone given via an implanted pump in combination with weekly intravenous irinotecan as adjuvant treatment after resection of hepatic metastases in patients with hepatic metastases from colorectal cancer The MTDs of irinotecan and floxuridine have been reached as of 101503 phase I closed to accrual as of 101503
Determine the efficacy of this combination chemotherapy after liver resection in terms of 2-year survival and 2-year recurrence rates in these patients
Determine the pharmacokinetic effects of intrahepatic FUDR and liver resection on the metabolism of irinotecan to its active metabolite SN-38 in these patients
Determine the safety and efficacy of the pump used in delivering intra-arterial chemotherapy to the liver in these patients
OUTLINE This is a dose-escalation study of floxuridine and irinotecan
Patients undergo hepatic resection and pump placement into the abdomen About 4 weeks after surgery patients receive irinotecan IV over 30 minutes on days 1 and 15 Patients also receive floxuridine and dexamethasone intra-arterially via an implanted pump continuously on days 1-14 Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or disease progression
Sequential dose escalation of irinotecan is followed by sequential dose escalation of floxuridine Cohorts of 3-6 patients receive escalating doses of irinotecan and floxuridine until the maximum tolerated doses MTDs are determined The MTD phase II dose is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
NOTE The MTDs of irinotecan and floxuridine have been reached as of 101503 phase I closed to accrual as of 101503
Patients are followed every 3 months for 2 years every 4 months for 2-4 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 2-24 patients will be accrued for the phase I portion of this study within 1 year phase I closed to accrual as of 101503 A total of 50 additional patients will be accrued for this study at the phase II dose level
Determine the maximum tolerated dose MTD of hepatic arterial infusion of floxuridine FUDR and dexamethasone given via an implanted pump in combination with weekly intravenous irinotecan as adjuvant treatment after resection of hepatic metastases in patients with hepatic metastases from colorectal cancer The MTDs of irinotecan and floxuridine have been reached as of 101503 phase I closed to accrual as of 101503
Determine the efficacy of this combination chemotherapy after liver resection in terms of 2-year survival and 2-year recurrence rates in these patients
Determine the pharmacokinetic effects of intrahepatic FUDR and liver resection on the metabolism of irinotecan to its active metabolite SN-38 in these patients
Determine the safety and efficacy of the pump used in delivering intra-arterial chemotherapy to the liver in these patients
OUTLINE This is a dose-escalation study of floxuridine and irinotecan
Patients undergo hepatic resection and pump placement into the abdomen About 4 weeks after surgery patients receive irinotecan IV over 30 minutes on days 1 and 15 Patients also receive floxuridine and dexamethasone intra-arterially via an implanted pump continuously on days 1-14 Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or disease progression
Sequential dose escalation of irinotecan is followed by sequential dose escalation of floxuridine Cohorts of 3-6 patients receive escalating doses of irinotecan and floxuridine until the maximum tolerated doses MTDs are determined The MTD phase II dose is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
NOTE The MTDs of irinotecan and floxuridine have been reached as of 101503 phase I closed to accrual as of 101503
Patients are followed every 3 months for 2 years every 4 months for 2-4 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 2-24 patients will be accrued for the phase I portion of this study within 1 year phase I closed to accrual as of 101503 A total of 50 additional patients will be accrued for this study at the phase II dose level
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-H99-0024 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066876 | REGISTRY | None | None |
| MSKCC-98072A9 | None | None | None |