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Trial record 72 of 147 for:    colon cancer AND Capecitabine AND colon cancer

Safety of Xeloda in Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02479217
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Metastatic Breast Cancer, Colon Cancer Drug: Docetaxel Drug: Xeloda

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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 : July 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Group/Cohort 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



Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: within 18 months ]

Secondary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: within 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with early or metastatic colon cancer, and patients with metastatic breast cancer, no age limit
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479217


Locations
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Serbia
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02479217    
Other Study ID Numbers: ML20367
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites