Safety of Xeloda in Solid Tumours

NCT ID: NCT02479217

Last Updated: 2017-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1268 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer, Colon Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Adjuvant therapy

Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer

Xeloda

Intervention Type DRUG

Combination Therapy

Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression

Docetaxel

Intervention Type DRUG

Xeloda

Intervention Type DRUG

Monotherapy

Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer

Xeloda

Intervention Type DRUG

Interventions

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Docetaxel

Intervention Type DRUG

Xeloda

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Kamenitz, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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ML20367

Identifier Type: -

Identifier Source: org_study_id

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