Safety of Xeloda in Solid Tumours

Metastatic Breast Cancer, Colon Cancer Clinical Trial

Official title:

Safety of Xeloda in Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479217
• Other study ID #: ML20367
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: February 16, 2017
• Start date: July 2006
• Est. completion date: June 2009

Study information

• Verified date: February 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1268
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Metastatic Breast Cancer, Colon Cancer

Intervention

Drug:
• Docetaxel

• Xeloda

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events		within 18 months
Secondary	Disease free survival (DFS)		within 18 months