Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025688
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2001-10-11
Brief Title:
Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of Weekly Taxol Paclitaxel Versus Weekly Taxol Plus Paraplatin Carboplatin as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-09
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 It is not yet known if paclitaxel is more effective with or without carboplatin in treating stage IV breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer
Detailed Description:
OBJECTIVES
Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer
Compare the overall survival time to disease progression and duration of response in these patients treated with these regimens
Compare the safety of these regimens in this patient population
Compare the quality of life of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to prior adjuvant chemotherapy yes vs no and ECOG performance status 0-1 vs 2 Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 1 hour weekly for 3 weeks
Arm IIPatients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 3 weeks
Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each course during study and then after completion of study
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 220 patients will be accrued for this study
Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer
Compare the overall survival time to disease progression and duration of response in these patients treated with these regimens
Compare the safety of these regimens in this patient population
Compare the quality of life of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to prior adjuvant chemotherapy yes vs no and ECOG performance status 0-1 vs 2 Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 1 hour weekly for 3 weeks
Arm IIPatients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 3 weeks
Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each course during study and then after completion of study
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 220 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 |
|---|---|---|---|
| BMS-TAXMEN13 | None | None | None |
| THERADEX-B00-1370 | None | None | None |