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

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: Colorectal Cancer
• Intervention / Treatment: Biological: Bevacizumab; Biological: Capecitabine; Drug: Oxaliplatin

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

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

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

How is the study designed?

Number of groups / cohorts

1

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	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)	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	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

• Sponsor: Hoffmann-La Roche

Study record dates

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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Capecitabine; Oxaliplatin; Bevacizumab
• Other Study ID Numbers: ML25523