Safety of Xeloda in Solid Tumours

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.

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Key information

Conditions

Metastatic Breast Cancer, Colon Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kamenitz, 21204, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

Xeloda

Drug

Primary outcomes

Number of Participants with Adverse Events

Time frame: within 18 months

Secondary outcomes

Disease free survival (DFS)

Time frame: within 18 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Jun 24, 2015
Registry last updated: Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed