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

August 4, 2016 updated by: Hoffmann-La Roche

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with colorectal cancer on first-line treatment with bevacizumab in combination with capecitabine and oxaliplatin.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bevacizumab
Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.
Biological: Bevacizumab
Bevacizumab administered according to prescribing information and normal clinical practice.
Other Names:
  • Avastin®
Biological: Capecitabine
Capecitabine administered according to prescribing information and normal clinical practice.
Other Names:
  • Xeloda®
Drug: Oxaliplatin
Capecitabine administered according to prescribing information and normal clinical practice.
Other Names:
  • Eloxatin™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: From randomization to progression or death during the study (up to approximately 30 months)
Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.
From randomization to progression or death during the study (up to approximately 30 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Tumor Assessments According to RECIST)
Time Frame: Up to approximately 30 months
Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR
Up to approximately 30 months
Percentage of Participants With Adverse Events
Time Frame: Up to approximately 30 months
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to approximately 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25523

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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