Trial Information
Randomised Phase II Trial of Bevacizumab (AVASTINĀ®) in Combination With Gemcitabine or Attenuated Doses of Cisplatin and Gemcitabine as First-line Treatment of Elderly Patients With Advanced Non-squamous Non-small Cell Lung Cancer - EAGLES
Inclusion Criteria:
- adult patients, >=70 years of age;
- inoperable, locally advanced, metastatic non-squamous non-small cell lung cancer;
- >=1 measurable lesion;
- ECOG performance status 0-1.
Exclusion Criteria:
- neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment;
- radical radiotherapy with curative intent within 28 days prior to enrollment;
- history of >=grade 2 hemoptysis in 3 months prior to enrollment;
- evidence of CNS metastases;
- current or recent (within 10 days of first dose of Avastin)use of aspirin (>325
mg/day)or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
Type of Study:
Interventional
Study Design:
Allocation: 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:
Italy: Ministry of Health
Study ID:
ML21868
NCT ID:
NCT01077713
Start Date:
February 2010
Completion Date:
October 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms