Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003730
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Multicenter Randomized Trial With Direct Individual Benefit to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy
PURPOSE Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy
Detailed Description:
OBJECTIVES
Determine the least toxic time of vinorelbine administration when combined with chronomodulated fluorouracil in women with previously treated metastatic breast cancer
Determine the toxic effects and dose intensities of each drug in these women
OUTLINE This is a randomized multicenter study Patients are stratified according to prior chemotherapy second line vs third line and participating center Patients are randomized to 1 of 8 vinorelbine dosing times 0000 0300 0600 0900 1200 1500 1800 or 2100
Patients receive vinorelbine IV over 20 minutes on days 1 and 6 and fluorouracil IV over 12 hours according to a chronomodulated delivery rate 2200 to 1000 with a maximum dose at 0400 on days 1-4 Treatment repeats every 3 weeks for at least 3 courses in the absence of unacceptable toxicity
Patients are followed for 30 days
PROJECTED ACCRUAL A minimum of 80 patients 10 per dosing time will be accrued for this study
Determine the least toxic time of vinorelbine administration when combined with chronomodulated fluorouracil in women with previously treated metastatic breast cancer
Determine the toxic effects and dose intensities of each drug in these women
OUTLINE This is a randomized multicenter study Patients are stratified according to prior chemotherapy second line vs third line and participating center Patients are randomized to 1 of 8 vinorelbine dosing times 0000 0300 0600 0900 1200 1500 1800 or 2100
Patients receive vinorelbine IV over 20 minutes on days 1 and 6 and fluorouracil IV over 12 hours according to a chronomodulated delivery rate 2200 to 1000 with a maximum dose at 0400 on days 1-4 Treatment repeats every 3 weeks for at least 3 courses in the absence of unacceptable toxicity
Patients are followed for 30 days
PROJECTED ACCRUAL A minimum of 80 patients 10 per dosing time will be accrued for this study
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 |
|---|---|---|---|
| EORTC-05971 | None | None | None |