Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer

Sponsor
PD Dr. med. Wolfgang Schuette
Study ID
NCT00976456
Phase
PHASE3
Status
Completed

Conditions

  • Non-squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab + Pemetrexed — DRUG
    Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks
  • Bevacizumab + Pemetrexed + Carboplatin — DRUG
    Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks

Study Details

Multi-center, open, randomized (parallel) and comparative phase III. Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression. Arm A: Bevacizumab + pemetrexed Arm B: Bevacizumab + pemetrexed + carboplatin

Key Dates

First listed
Sep 14, 2009
Start date
Sep 30, 2009
Status verified
Feb 2016
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

Enrollment
271 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bevacizumab + Pemetrexed
    Bevacizumab + Pemetrexed
  • Active Comparator: Bevacizumab + Pemetrexed + Carboplatin
    Bevacizumab + Pemetrexed + Carboplatin

Primary Outcome Measure

Progression Free Survival [ Time Frame: 42 months ]

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