Metastatic Breast Cancer Clinical Trial
Official title:
A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer
Verified date | February 2012 |
Source | Cancer Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.
Status | Completed |
Enrollment | 18 |
Est. completion date | |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cancer Research Network, Inc. | Plantation | Florida |
Lead Sponsor | Collaborator |
---|---|
Cancer Research Network | Hoffmann-La Roche |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination | 2 years | No |
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