Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00006120
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2000-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
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?: