Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154882
Status:
UNKNOWN
Last Update Posted:
2010-01-21
First Post:
2005-09-08
Brief Title:
Paclitaxel Phyxol and Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Weekly Low-dose Paclitaxel Phyxol Plus 24-Hour Infusion of Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2005-07
Last Known Status:
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:
The primary endpoint of this phase II trial is the objective response rate of the stage I low-dose regimen The secondary endpoints include treatment-related toxicity the change in quality of life progression free survival and overall survival
Detailed Description:
Breast cancer is one of the leading causes of cancer death for women in Taiwan We have recently demonstrated that combination of paclitaxel and cisplatin at conventional doses is highly effective in the treatment of breast cancer However the acute and cumulative toxicities of paclitaxel have been troublesome to a significant portion of the patients Several lines of evidence suggested that weekly paclitaxel at a much lower dose range of 40 to 50 mgm2 per week may be as effective as that of the conventional doses of paclitaxel 80 to 90 mgm2 per week for patients with metastatic ovarian and lung cancers The low-dose regimen of paclitaxel may significantly improve the compliance of the patients This open-label phase II trial is designed to test this hypothesis
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