An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis
Inclusion Criteria:
- adult patients, >=18 years of age;
- stage IV non-squamous non-small cell lung cancer;
- asymptomatic, untreated brain metastasis;
- ECOG performance status 0-1.
Exclusion Criteria:
- previous treatment for brain metastasis;
- history of migraine or epilepsy;
- previous treatment with angiogenesis inhibitors;
- for cohort 2, previous first line treatment with Avastin or Tarceva;
- current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or
thrombolytic agent for therapeutic purposes.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France:AFSSAPS
Study ID:
ML21823
NCT ID:
NCT00800202
Start Date:
April 2009
Completion Date:
October 2012
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Metastasis
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