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Randomised Phase II Trial of Bevacizumab (AVASTIN®) 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
This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Age
70 - No limit years
Sex
ALL
Healthy Volunteers
No
Rionero in Vulture, Basilicate, Italy
Catanzaro, Calabria, Italy
Avellino, Campania, Italy
Naples, Campania, Italy
Bologna, Emilia-Romagna, Italy
Aviano, Friuli Venezia Giulia, Italy
Udine, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Start Date
February 1, 2010
Primary Completion Date
July 1, 2014
Completion Date
July 1, 2014
Last Updated
October 8, 2015
86
ACTUAL participants
bevacizumab [Avastin]
DRUG
cisplatin
DRUG
gemcitabine
DRUG
gemcitabine
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT06627647
NCT06417008
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06311721