Status:
COMPLETED
A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer
Lead Sponsor:
Cancer Research Network
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00214864
Start Date
December 1 2002
Last Update
February 14 2012
Active Locations (1)
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1
Cancer Research Network, Inc.
Plantation, Florida, United States, 33324