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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


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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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

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