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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: August 4, 2016
Last verified: August 2016
  Purpose
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).

Condition Intervention
Colorectal Cancer Biological: Bevacizumab Biological: Capecitabine Drug: Oxaliplatin

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 [ 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.


Secondary Outcome Measures:
  • 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

  • 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.


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)
Groups/Cohorts Assigned Interventions
Bevacizumab
Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.
Biological: Bevacizumab
Bevacizumab administered according to prescribing information and normal clinical practice.
Other Name: Avastin®
Biological: Capecitabine
Capecitabine administered according to prescribing information and normal clinical practice.
Other Name: Xeloda®
Drug: Oxaliplatin
Capecitabine administered according to prescribing information and normal clinical practice.
Other Name: Eloxatin™

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with colorectal cancer on first-line treatment with bevacizumab in combination with capecitabine 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01399190     History of Changes
Other Study ID Numbers: ML25523
Study First Received: July 20, 2011
Results First Received: August 4, 2016
Last Updated: August 4, 2016

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

ClinicalTrials.gov processed this record on June 23, 2017