CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
bevacizumab [Avastin] +3 moredrug
Likely dose
bevacizumab [Avastin] 15mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00800202
NCT00800202Phase 2Completed

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

Hoffmann-La Roche·interventional·Posted Dec 2, 2008·Updated Nov 19, 2014

In Brief

A Phase 2 clinical trial evaluating bevacizumab [Avastin], carboplatin, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 91 participants across 25 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2008
Enrollment StartApr 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.6 years ago

Interventions

bevacizumab [Avastin]drug

15mg/kg iv every 3 weeks

carboplatindrug

AUC6 iv every 3 weeks for 6 cycles

erlotinib [Tarceva]drug

150mg/day po

paclitaxeldrug

200mg/m2 iv every 3 weeks for 6 cycles