Status:
COMPLETED
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients ...
Eligibility Criteria
Inclusion
- Adult patients, ≥ 18 years of age.
- Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.
- At least 1 measurable lesion.
- Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.
Exclusion
- Previous treatment with Avastin.
- Previous systemic treatment for advanced or metastatic disease.
- clinically significant cardiovascular disease.
- Daily chronic treatment with high doses of aspirin (\> 325 mg/day) or non-steroidal anti-inflammatory drugs.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00623805
Start Date
March 1 2008
End Date
May 1 2012
Last Update
August 8 2014
Active Locations (10)
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1
Ankara, Turkey (Türkiye), 06100
2
Ankara, Turkey (Türkiye), 06500
3
Ankara, Turkey (Türkiye), 06590
4
Gaziantep, Turkey (Türkiye), 27310