Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002842
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
1999-11-01
Brief Title:
Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-02
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 Combining more than one drug and giving drugs in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer
PURPOSE Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Evaluate the efficacy of hepatic resection followed by portal vein infusion of floxuridine plus systemic fluorouracilleucovorin calcium in patients with metastatic colorectal cancer
Study the toxic effects of adjuvant chemotherapy following hepatic resection
Evaluate mRNA expression of enzymes that may be important to the cytotoxicity of fluoropyrimidines in tumor cells including thymidylate synthase ribonucleotide reductase and folylglutamyl synthetase by polymerase chain reaction and immunohistochemistry
OUTLINE Following resection of the liver and all extrahepatic colorectal cancer patients receive floxuridine via portal vein infusion from days 1-14 Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13 Courses repeat every 4 weeks for a total of 12 weeks
If biopsy-proven metastatic disease develops treatment may be stopped at the investigators discretion Continuation of regional therapy should be considered for extrahepatic failure No concurrent radiotherapy is permitted
Patients are followed every 3 months for 3 years then every 6 months for survival
PROJECTED ACCRUAL It is expected that 50 patients will be entered over approximately 5 years
Evaluate the efficacy of hepatic resection followed by portal vein infusion of floxuridine plus systemic fluorouracilleucovorin calcium in patients with metastatic colorectal cancer
Study the toxic effects of adjuvant chemotherapy following hepatic resection
Evaluate mRNA expression of enzymes that may be important to the cytotoxicity of fluoropyrimidines in tumor cells including thymidylate synthase ribonucleotide reductase and folylglutamyl synthetase by polymerase chain reaction and immunohistochemistry
OUTLINE Following resection of the liver and all extrahepatic colorectal cancer patients receive floxuridine via portal vein infusion from days 1-14 Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13 Courses repeat every 4 weeks for a total of 12 weeks
If biopsy-proven metastatic disease develops treatment may be stopped at the investigators discretion Continuation of regional therapy should be considered for extrahepatic failure No concurrent radiotherapy is permitted
Patients are followed every 3 months for 3 years then every 6 months for survival
PROJECTED ACCRUAL It is expected that 50 patients will be entered over approximately 5 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 |
|---|---|---|---|
| CDR0000065077 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-IRB-94080 | None | None | None |
| NCI-V96-1031 | None | None | None |