An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01399190
First received: July 20, 2011
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This prospective observational study will evaluate the efficacy and safety of Av astin (bevacizumab) in combination with Xeloda (capecitabine) and oxaliplatin as first-line treatment in patients with colorectal cancer. Data will be collected from each patient until disease progression occurs (for up to 30 months).


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival (tumour assessments according to RECIST criteria) [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (tumour assessments according to RECIST criteria) [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: July 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with colorectal cancer on first-line treatment with Avastin in combination with Xeloda and oxaliplatin

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Metastatic colorectal cancer
  • Treatment in accordance with current Summary of Product Characteristics and local guidelines

Exclusion Criteria:

  • Contraindications according to current Summary of Product Characteristics and local guidelines
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399190

Locations
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 812 50
Bratislava, Slovakia, 833 10
Kosice, Slovakia, 04001
Martin, Slovakia, 036 59
Nitra, Slovakia, 950 01
Poprad, Slovakia, 058 01
Presov, Slovakia, 081 81
Ruzomberok, Slovakia, 03426
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01399190     History of Changes
Other Study ID Numbers: ML25523
Study First Received: July 20, 2011
Last Updated: October 13, 2014
Health Authority: Slovakia: State Institute for the Control of Drugs

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Capecitabine
Oxaliplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014