Safety of Xeloda in Solid Tumours

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02479217
• Collaborator: (none)
• Enrollment: 1,268
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 36.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer, Colon Cancer	Drug: Docetaxel; Drug: Xeloda

Study Design

• Study Type: Observational
• Actual Enrollment: 1268 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Safety of Xeloda in Solid Tumours
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Adjuvant therapy Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer	Drug: Xeloda
Combination Therapy Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression	Drug: Docetaxel; Drug: Xeloda
Monotherapy Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer	Drug: Xeloda

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events [within 18 months]

Secondary Outcome Measures

1. Disease free survival (DFS) [within 18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Sremska Kamenica		Serbia	21204

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02479217
• Other Study ID Numbers: ML20367
• First Posted: Jun 24, 2015
• Last Update Posted: Feb 17, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Colonic Neoplasms; Docetaxel

Study Results

No Results Posted as of Feb 17, 2017