Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008411
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2001-01-06
Brief Title:
Docetaxel in Treating Patients With Metastatic Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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
PURPOSE Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Compare the objective tumor response rate duration of response time to progression progression-free survival and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks
Compare the safety and toxicity of these regimens in these patients
Evaluate the maintenance of relative dose intensity with each regimen in these patients
Correlate pretreatment serum HER2neu level and response with docetaxel therapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior taxane use yes vs no number of prior chemotherapy regimens for metastatic disease 0 vs 1 and participating center Patients are randomized to one of two treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1 Courses repeat every 21 days
Arm II Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks at 3 6 9 and 12 months and then annually for 4 years
PROJECTED ACCRUAL A total of 160 patients will be accrued for this study
Compare the objective tumor response rate duration of response time to progression progression-free survival and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks
Compare the safety and toxicity of these regimens in these patients
Evaluate the maintenance of relative dose intensity with each regimen in these patients
Correlate pretreatment serum HER2neu level and response with docetaxel therapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior taxane use yes vs no number of prior chemotherapy regimens for metastatic disease 0 vs 1 and participating center Patients are randomized to one of two treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1 Courses repeat every 21 days
Arm II Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks at 3 6 9 and 12 months and then annually for 4 years
PROJECTED ACCRUAL A total of 160 patients 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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-ID-99242 | OTHER | None | None |
| AVENTIS-MDA-ID-99242 | None | None | None |
| NCI-1691 | None | None | None |
| CDR0000068408 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |