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

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: NCT01399190
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : September 28, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date July 20, 2011
First Posted Date July 21, 2011
Results First Submitted Date August 4, 2016
Results First Posted Date September 28, 2016
Last Update Posted Date September 28, 2016
Study Start Date July 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2016)
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.
Original Primary Outcome Measures
 (submitted: July 20, 2011)
Progression-free survival (tumour assessments according to RECIST criteria) [ Time Frame: approximately 30 months ]
Change History Complete list of historical versions of study NCT01399190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 4, 2016)
  • 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.
Original Secondary Outcome Measures
 (submitted: July 20, 2011)
  • Response rate (tumour assessments according to RECIST criteria) [ Time Frame: approximately 30 months ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 30 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer
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
Brief Summary 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with colorectal cancer on first-line treatment with bevacizumab in combination with capecitabine and oxaliplatin.
Condition Colorectal Cancer
Intervention
  • 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™
Study Groups/Cohorts Bevacizumab
Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.
Interventions:
  • Biological: Bevacizumab
  • Biological: Capecitabine
  • Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 9, 2013)
68
Original Estimated Enrollment
 (submitted: July 20, 2011)
50
Actual Study Completion Date February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01399190
Other Study ID Numbers ML25523
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2016