Clinical trial NCT01077713: A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 86
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=70 years of age;
* inoperable, locally advanced, metastatic non-squamous non-small cell lung cancer;
* \>=1 measurable lesion;
* ECOG performance status 0-1.

Exclusion Criteria:

* neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment;
* radical radiotherapy with curative intent within 28 days prior to enrollment;
* history of \>=grade 2 hemoptysis in 3 months prior to enrollment;
* evidence of CNS metastases;
* current or recent (within 10 days of first dose of Avastin)use of aspirin (\>325 mg/day)or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

Primary outcomes:
measure: Percentage of Participants Alive and Without Progressive Disease at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)
measure: Progression Free Survival (PFS)
timeFrame: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)
measure: Percentage of Participants Alive at 12 Months After Randomization
timeFrame: 1 year
measure: Percentage of Participants Who Died
timeFrame: From randomization to death or end of the study (up to 53 months)
measure: Overall Survival (OS)
timeFrame: From randomization to death or end of the study (up to 53 months)
measure: Percentage of Participants by Best Overall Response
timeFrame: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)
measure: Percentage of Participants With an Objective Response
timeFrame: Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6
measure: Percentage of Participants With Disease Control
timeFrame: Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6
measure: Duration of Response (DoR)
timeFrame: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)
Other outcomes:
Locations:
city: Rionero in Vulture
country: Italy
state: Basilicata
city: Catanzaro
country: Italy
state: Calabria
city: Avellino
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Aviano
country: Italy
state: Friuli-Venezia Giulia
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Viterbo
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: Bergamo
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Rho
country: Italy
state: Lombardia
city: Sondalo
country: Italy
state: Lombardia
city: Sondrio
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Pesaro
country: Italy
state: Marche
city: Novara
country: Italy
state: Piemonte
city: Catania
country: Italy
state: Sicilia
city: Lido Di Camaiore
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Mirano
country: Italy
state: Veneto
city: Padova
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: