Safety of Xeloda in Solid Tumours

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Docetaxel

Criteria

Inclusion Criteria:

Metastatic Breast Cancer:

• women >=18 years of age

• Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.

• Previous therapy should have included an anthracycline.

• Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

• Female patients with histopathologically proven metastatic breast cancer

• Adequate bone marrow, liver, renal and cardiac functions

Colon Cancer:

• Patients >18 years of age

• Patients with histologicaly confirmed colon cancer

• Patients with potential curative tumor resection within 8 weeks before enrolment in the study

• Patients previously not treated with chemiotherapy

Exclusion Criteria:

Metastatic Breast Cancer:

• Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda)

• Patients with contraindications for any of study drugs as listed in approved SmPC

Colon Cancer:

• Patients previously treated with chemiotherapy

• Patients with contraindications for study drug as listed in approved SmPC