A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research Network
• Collaborator: Hoffmann-La Roche
• Treatments: Capecitabine; Docetaxel

Criteria

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.