Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer
Inclusion Criteria:
- Adult patients >=18 years of age
- Locally advanced or metastatic colorectal cancer
- No previous treatment with chemotherapy for metastatic disease
- Measurable and/or evaluable lesions
Exclusion Criteria:
- Radiotherapy within 4 weeks before study
- Untreated brain metastases or primary brain tumors
- Chronic, daily treatment with high-dose aspirin (>325mg/day)
- Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the
exception of basal and squamous cell cancer, or cervical cancer in situ
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:
Overall response rate (ORR: complete and partial response); tumor assessments by Computer Tomography (CT) scan or by Magnetic Resonance Imaging (MRI)
Outcome Time Frame:
3.5 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Italian Medicines Agency (AIFA)
Study ID:
ML18523
NCT ID:
NCT01159171
Start Date:
January 2006
Completion Date:
July 2010
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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