A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer|
- To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2002|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Drug: docetaxel, capecitabine
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 capecitabine/weekly 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 mg/m2 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 and/or 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.
|United States, Florida|
|Cancer Research Network, Inc.|
|Plantation, Florida, United States, 33324|
|Principal Investigator:||Charles L Vogel, MD||Cancer Research Network, Inc|
|Study Chair:||Elizabeth Tan-Chiu, MD||Cancer Research Network, Inc.|