Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214864
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2005-09-15
Brief Title:
A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer
Sponsor:
Cancer Research Network
Organization:
Cancer Research Network
Study Overview
Official Title:
A Pilot Study of Taxotere Docetaxel Combined With Xeloda Capecitabine in the Treatment of Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen
Detailed Description:
Combination chemotherapy has advantages over monochemotherapy due to the higher response rates that can often be obtained by using agents with non-overlapping toxicity profiles these responses can be achieved with less toxicity than maximally tolerated doses of single agents One significant advantage of capecitabineweekly docetaxel combination chemotherapy is that both agents appear to have a toxicity profile appropriate for palliative therapy of advanced breast cancer This trial will utilize the usual schedule of capecitabine used in the USA which is two times per day oral dosing for 14 days but at a reduced dose in hopes of decreasing toxicities Docetaxel will be given weekly at a dose of 35 mgm2 X 2 with a one-week rest to coincide with the 14-day schedule of capecitabine
The primary objective is to evaluate the overall response rate complete and partial responses according to the RECIST criteria of the combination of capecitabine and docetaxel with the selected schedule in patients with advanced andor metastatic breast cancer The secondary objectives are to evaluate tolerability time to tumor progression and time to treatment failure of the combination of capecitabine and docetaxel
The primary objective is to evaluate the overall response rate complete and partial responses according to the RECIST criteria of the combination of capecitabine and docetaxel with the selected schedule in patients with advanced andor metastatic breast cancer The secondary objectives are to evaluate tolerability time to tumor progression and time to treatment failure of the combination of capecitabine and docetaxel
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