Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006120
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2000-08-03
Brief Title:
Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Compare the response rate progression free survival and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel
Compare the toxicities and pharmacoeconomics of these four regimens in these patients
Compare the quality of life of patients treated with these four regimens
OUTLINE This is a randomized multicenter study Patients are stratified by center age ECOG performance status hormone receptor status positive vs negative metastasis to liver yes vs no and presence of disease progression following anthracyclines yes vs no
Patients are randomized to one of four treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1
Arm II Patients receive paclitaxel IV over 3 hours on day 1
Arm III Patients receive docetaxel IV over 1 hour on days 1 8 15 22 29 and 36
Arm IV Patients receive paclitaxel IV over 1 hour on days 1 8 15 22 29 and 36
Courses repeat every 3 weeks arms I and II or every 8 weeks arms III and IV in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to treatment and then every 8 weeks
PROJECTED ACCRUAL A total of 165 patients will be accrued for this study
Compare the response rate progression free survival and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel
Compare the toxicities and pharmacoeconomics of these four regimens in these patients
Compare the quality of life of patients treated with these four regimens
OUTLINE This is a randomized multicenter study Patients are stratified by center age ECOG performance status hormone receptor status positive vs negative metastasis to liver yes vs no and presence of disease progression following anthracyclines yes vs no
Patients are randomized to one of four treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1
Arm II Patients receive paclitaxel IV over 3 hours on day 1
Arm III Patients receive docetaxel IV over 1 hour on days 1 8 15 22 29 and 36
Arm IV Patients receive paclitaxel IV over 1 hour on days 1 8 15 22 29 and 36
Courses repeat every 3 weeks arms I and II or every 8 weeks arms III and IV in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to treatment and then every 8 weeks
PROJECTED ACCRUAL A total of 165 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20029 | None | None | None |
| FRE-GERCOR-TAXMAX-SOO-1 | None | None | None |