A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

Sponsor
Hoffmann-La Roche
Study ID
NCT00800202
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    15mg/kg iv every 3 weeks
  • carboplatin — DRUG
    AUC6 iv every 3 weeks for 6 cycles
  • erlotinib [Tarceva] — DRUG
    150mg/day po
  • paclitaxel — DRUG
    200mg/m2 iv every 3 weeks for 6 cycles

Study Details

This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.

Key Dates

First listed
Dec 2, 2008
Start date
Apr 30, 2009
Status verified
Nov 2014
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
91 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months [ Time Frame: 6 months ]

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