A Phase 2 interventional study of docetaxel, capecitabine in Metastatic Breast Cancer, sponsored by Cancer Research Network. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-02-14.
Sponsored by Cancer Research Network · Phase 2, Interventional, and Treatment
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 18 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Cancer Research Network is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
cohort 1 = capecitabine 900mg/m2 BID POx14 days and docetaxel 36mg/m2 day1\&8 cohort 2 = capecitabine 650mg/m2 BID POx14 days and docetaxel 30mg/m2 day1\&8 cohort 3 = capecitabine 850mg/m2 BID POx14 days and docetaxel 30mg/m2 day1\&8
To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination
Time frame: 2 years
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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