Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008294
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2001-01-06
Brief Title:
Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study Of Hepatic Arterial Infusion With Floxuridine And Dexamethasone In Combination With Intravenous Oxaliplatin Plus 5-Fluorouracil And Leucovorin In Patients With Unresectable Hepatic Metastases From Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 Cryosurgery kills cancer cells by freezing them Combining more than one chemotherapy drug with cryosurgery and giving drugs in different ways may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of intrahepatic and intravenous combination chemotherapy with or without cryosurgery in treating unresectable liver metastases from colorectal cancer
PURPOSE Phase I trial to study the effectiveness of intrahepatic and intravenous combination chemotherapy with or without cryosurgery in treating unresectable liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of oxaliplatin and fluorouracil when given with leucovorin calcium and hepatic intra-arterial floxuridine and dexamethasone with or without cryosurgery group I cryosurgery closed to accrual as of 101303 in patients with unresectable liver metastases from colorectal cancer
Determine preliminarily the anti-tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of oxaliplatin and fluorouracil Patients are assigned to one of two treatment groups Group I closed to accrual as of 101303
Group I closed to accrual as of 101303 Patients with no more than 8 hepatic metastases and no metastases greater than 5 cm in diameter undergo cryosurgery prior to chemotherapy Chemotherapy is delayed for at least 4 weeks after cryosurgery
Group II Patients with more than 8 hepatic metastases or at least one metastases greater than 5 cm in diameter do not undergo cryosurgery prior to chemotherapy
Beginning 2 weeks after pump placement surgery all patients receive floxuridine and dexamethasone by hepatic intra-arterial infusion continuously on days 1-14 oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on days 15 and 29 and fluorouracil IV continuously over 48 hours on days 15-16 and 29-30 Courses repeat every 36 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 4-72 patients will be accrued for this study within 18 months
Determine the maximum tolerated dose of oxaliplatin and fluorouracil when given with leucovorin calcium and hepatic intra-arterial floxuridine and dexamethasone with or without cryosurgery group I cryosurgery closed to accrual as of 101303 in patients with unresectable liver metastases from colorectal cancer
Determine preliminarily the anti-tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of oxaliplatin and fluorouracil Patients are assigned to one of two treatment groups Group I closed to accrual as of 101303
Group I closed to accrual as of 101303 Patients with no more than 8 hepatic metastases and no metastases greater than 5 cm in diameter undergo cryosurgery prior to chemotherapy Chemotherapy is delayed for at least 4 weeks after cryosurgery
Group II Patients with more than 8 hepatic metastases or at least one metastases greater than 5 cm in diameter do not undergo cryosurgery prior to chemotherapy
Beginning 2 weeks after pump placement surgery all patients receive floxuridine and dexamethasone by hepatic intra-arterial infusion continuously on days 1-14 oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on days 15 and 29 and fluorouracil IV continuously over 48 hours on days 15-16 and 29-30 Courses repeat every 36 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 4-72 patients will be accrued for this study within 18 months
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-G00-1896 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-00009 | None | None | None |