Status:
COMPLETED
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progr...
Eligibility Criteria
Inclusion
- Adult patients, \>=18 years of age
- Metastatic colorectal cancer and disease progression
- Previously treated with first-line chemotherapy plus Avastin
- Eastern Cooperative Oncology Group (ECOG) performance status \<=2.
Exclusion
- Diagnosis of progression of disease more than 3 months after last Avastin administration
- First-line patients with progression-free survival in first-line of \<3 months
- Patients receiving less than 3 consecutive months of Avastin in first-line therapy
- Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
- Clinically significant cardiovascular disease within 6 months prior to start of study treatment
- Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT00700102
Start Date
February 1 2006
End Date
May 1 2013
Last Update
July 30 2015
Active Locations (300)
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1
Dornbirn, Austria, 6850
2
Fürstenfeld, Austria, 8280
3
Graz, Austria, 8020
4
Graz, Austria, 8036