Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026234
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2001-11-09
Brief Title:
Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Evaluating Multiple Metastasectomy Combined With Hepatic Artery Infusion Of Floxuridine FUDR And Dexamethasone DXM Alternating With Systemic Oxaliplatin OXAL And Capecitabine CAPCIT For Colorectal Carcinoma Metastatic To The Liver
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:
Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving the drugs in different combinations and different ways may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the safety and toxicity of hepatic arterial infusion with floxuridine and dexamethasone followed by systemic therapy with oxaliplatin and capecitabine in patients with surgically resected liver metastases from primary colorectal carcinoma
II Determine the 2-year survival rate of patients treated with this regimen III Determine the 2-year recurrence rate and time to recurrence in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14 oxaliplatin IV over 2 hours on day 22 and oral capecitabine twice daily on days 22-35 Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or unacceptable toxicity After completion of the fourth course patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 25 years
PROJECTED ACCRUAL A total of 15-75 patients will be accrued for this study within 9 months-325 years
I Determine the safety and toxicity of hepatic arterial infusion with floxuridine and dexamethasone followed by systemic therapy with oxaliplatin and capecitabine in patients with surgically resected liver metastases from primary colorectal carcinoma
II Determine the 2-year survival rate of patients treated with this regimen III Determine the 2-year recurrence rate and time to recurrence in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14 oxaliplatin IV over 2 hours on day 22 and oral capecitabine twice daily on days 22-35 Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or unacceptable toxicity After completion of the fourth course patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 25 years
PROJECTED ACCRUAL A total of 15-75 patients will be accrued for this study within 9 months-325 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 |
|---|---|---|---|
| U10CA025224 | NIH | None | httpsreporternihgovquickSearchU10CA025224 |
| N9945 | None | None | None |
| CDR0000069011 | None | None | None |
| NCCTG-N9945 | None | None | None |
| NSABP-CI-66 | None | None | None |