Status:
COMPLETED
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung can...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
- ECOG PS status 0-2;
- life expectancy \>= 12weeks;
- adequate renal, liver and hematological function.
Exclusion
- mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
- hemoptysis (\>=1/2 teaspoon of bright red blood) in previous 3 months;
- evidence of tumor invading major blood vessels on imaging;
- evidence of CNS metastases, even if previously treated.
- major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
- prior chemotherapy for stage IIIb/IV disease.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
2252 Patients enrolled
Trial Details
Trial ID
NCT00451906
Start Date
August 1 2006
End Date
June 1 2009
Last Update
May 24 2016
Active Locations (369)
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1
Buenos Aires, Argentina, 1272
2
Chaco-resistencia, Argentina, 3400
3
Córdoba, Argentina, 5000
4
Córdoba, Argentina, 5016