An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum
1 other identifier
observational
35
1 country
1
Brief Summary
This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedNovember 2, 2016
November 1, 2016
3 years
April 10, 2013
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Incidence of adverse events
approximately 3.5 years
Secondary Outcomes (1)
Efficacy: Time to disease progression
approximately 3.5 years
Study Arms (1)
Cohort
Eligibility Criteria
Patients with metastatic cancer of the colon and/or rectum
You may qualify if:
- Adult patients, \>/= 18 years of age
- Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases
- At least one measurable metastatic lesion (as per RECIST criteria)
- Life expectancy of \> 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematological, renal and liver function
You may not qualify if:
- Prior chemotherapy for metastatic disease
- Clinically significant cardiovascular disease
- Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose for gastrointestinal ulceration
- Participation in an investigational trial in the previous 3 months
- Pregnant or lactating women
- History of thrombotic or haemorrhagic disorders
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled hypertension
- Known hypersensitivity to Avastin and any of its excipients, or any of the chemotherapies
- Evidence of any disease or disorder that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Podgorica, 81000, Montenegro
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 12, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
November 2, 2016
Record last verified: 2016-11