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

Completed

• Conditions: Colorectal Cancer
• Interventions: Biological: Bevacizumab; Biological: Capecitabine; Drug: Oxaliplatin

• Registration Number: NCT01399190
• Lead Sponsor: Hoffmann-La Roche

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-21
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-08
• Results First Submitted: 2016-08-04
• Results First Submitted QC: 2016-08-04
• Last Update Submitted: 2016-08-04
• Results First Posted: 2016-09-28
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

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Exclusion Criteria

• Contraindications according to current Summary of Product Characteristics and local guidelines

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Bevacizumab	Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.
Bevacizumab	Capecitabine	Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.
Bevacizumab	Oxaliplatin	Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	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

Name	Time	Method
Response Rate (Tumor Assessments According to RECIST)	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	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.