Open-label, Efficacy and Safety Study of Bevacizumab (Avastin®) in Combination With XELOX (Oxaliplatin Plus Xeloda®) for the First-line Treatment of Patients With Metastatic Cancer of the Colon or Rectum - 'OBELIX'
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Open-label, Efficacy and Safety Study of Bevacizumab (Avastin®) in Combination With XELOX (Oxaliplatin Plus Xeloda®) for the First-line Treatment of Patients With Metastatic Cancer of the Colon or Rectum - 'OBELIX'
Inclusion Criteria:
- adult patients, >=18 years of age;
- locally advanced or metastatic colorectal cancer;
- no previous treatment with chemotherapy for metastatic disease;
- at least one measurable lesion.
Exclusion Criteria:
- radiotherapy to any site within 4 weeks before study;
- untreated brain metastases or primary brain tumors;
- clinically significant cardiovascular disease;
- chronic daily treatment with high dose aspirin (>325 mg/day);
- other co-existing malignancies or malignancies diagnosed within last 5 years.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML21380
NCT ID:
NCT00577031
Start Date:
February 2008
Completion Date:
August 2011
Related Keywords:
- Colorectal Cancer
- Colonic Neoplasms
- Colorectal Neoplasms
- Neoplasm Metastasis
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