A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.

Key facts

Study ID

NCT00214864

Run by

Cancer Research Network

People needed

18

Starts

2002-12-01

Last updated by the study team

2012-02-14

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients with histopathologically proven metastatic breast cancer.
• Patients 18-75 years old
• Performance status: Karnofsky > 70%
• Patients must have measurable disease. Patients with only blastic bone lesions are ineligible.
• Adequate bone marrow, liver, renal and cardiac functions defined as:
• Ability to understand the study and give informed consent.
• Patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-FU or Taxol given as part of an adjuvant regimen will not render the patient ineligible.

You may not qualify if…

• Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.
• Patients who have received any anti-cancer investigational agent in the month prior to inclusion.
• Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda).
• Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
• Patients with renal impairment (creatinine clearance below 30 ml/min calculated according to Cockcroft and Gault, see Appendix D), since capecitabine is contraindicated in patients with severe renal impairment.

Where it is running

• Cancer Research Network, Inc. — Plantation, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.