Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002716
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE FUDR LEUCOVORIN LV AND DEXAMETHASONE DEX VERSUS SYSTEMIC 5-FLUOROURACIL 5-FU AND LEUCOVORIN LV AS TREATMENT FOR HEPATIC METASTASES FROM COLORECTAL CANCER
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine leucovorin and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have unresectable liver metastases from colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine leucovorin and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have unresectable liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Compare the efficacy toxicity and cost of hepatic artery infusion of floxuridine leucovorin calcium CF and dexamethasone vs IV fluorouracil and IV CF after resection of primary disease in patients with hepatic metastases secondary to colorectal cancer
Compare the quality of life of patients treated with these regimens
Measure the level of thymidylate synthase present in liver metastases and correlate these levels with objective response and survival in patients treated with these regimens
Assess the p53 mutations and correlate findings with objective response and survival in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to center percentage of liver involvement on CT scan or MRI less than 30 vs 30 to under 70 prior chemotherapy none vs adjuvant chemotherapy comprising fluorouracil 5-FU and leucovorin calcium CF or 5-FU CF and levamisole LEV completed at least 1 year before study vs adjuvant chemotherapy comprising 5-FU with or without LEV completed at least 6 months before study and synchronous disease yes vs no Patients are randomized to 1 of 2 treatment arms
Compare the efficacy toxicity and cost of hepatic artery infusion of floxuridine leucovorin calcium CF and dexamethasone vs IV fluorouracil and IV CF after resection of primary disease in patients with hepatic metastases secondary to colorectal cancer
Compare the quality of life of patients treated with these regimens
Measure the level of thymidylate synthase present in liver metastases and correlate these levels with objective response and survival in patients treated with these regimens
Assess the p53 mutations and correlate findings with objective response and survival in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to center percentage of liver involvement on CT scan or MRI less than 30 vs 30 to under 70 prior chemotherapy none vs adjuvant chemotherapy comprising fluorouracil 5-FU and leucovorin calcium CF or 5-FU CF and levamisole LEV completed at least 1 year before study vs adjuvant chemotherapy comprising 5-FU with or without LEV completed at least 6 months before study and synchronous disease yes vs no Patients are randomized to 1 of 2 treatment arms
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 |
|---|---|---|---|
| CDR0000064553 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |