Clinical trial NCT00800202: A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* stage IV non-squamous non-small cell lung cancer;
* asymptomatic, untreated brain metastasis;
* ECOG performance status 0-1.

Exclusion Criteria:

* previous treatment for brain metastasis;
* history of migraine or epilepsy;
* previous treatment with angiogenesis inhibitors;
* for cohort 2, previous first line treatment with Avastin or Tarceva;
* current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.

Primary outcomes:
measure: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months
timeFrame: 6 months
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant
measure: Time to Disease Progression or Death
timeFrame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant
Secondary outcomes:
measure: Percentage of Participants Who Died
timeFrame: Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death
measure: Probability of Being Alive at 12 and 18 Months
timeFrame: Months 12 and 18
measure: Time to Death
timeFrame: Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death
measure: Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST
timeFrame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Brest
country: France
city: Caen
country: France
city: Chartres
country: France
city: Creteil
country: France
city: GAP
country: France
city: Gleize
country: France
city: La Tronche
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Rennes
country: France
city: Saint Herblain
country: France
city: Strasbourg
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Vandoeuvre Les Nancy
country: France
city: Vandoeuvre-les-nancy
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: