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
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
2 other identifiers
interventional
86
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2010
Typical duration for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
October 8, 2015
CompletedOctober 8, 2015
September 1, 2015
4.4 years
February 9, 2010
September 9, 2015
September 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Alive and Without Progressive Disease at Month 6
Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.
Month 6
Secondary Outcomes (9)
Percentage of Participants With Disease Progression or Death
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)
Progression Free Survival (PFS)
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)
Percentage of Participants Alive at 12 Months After Randomization
1 year
Percentage of Participants Who Died
From randomization to death or end of the study (up to 53 months)
Overall Survival (OS)
From randomization to death or end of the study (up to 53 months)
- +4 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Rionero in Vulture, Basilicate, 85028, Italy
Unknown Facility
Catanzaro, Calabria, 88100, Italy
Unknown Facility
Avellino, Campania, 83100, Italy
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Bologna, Emilia-Romagna, 40139, Italy
Unknown Facility
Aviano, Friuli Venezia Giulia, 33081, Italy
Unknown Facility
Udine, Friuli Venezia Giulia, 33100, Italy
Unknown Facility
Rome, Lazio, 00128, Italy
Unknown Facility
Rome, Lazio, 00152, Italy
Unknown Facility
Rome, Lazio, 00189, Italy
Unknown Facility
Viterbo, Lazio, 01100, Italy
Unknown Facility
Genoa, Liguria, 16149, Italy
Unknown Facility
Bergamo, Lombardy, 24128, Italy
Unknown Facility
Milan, Lombardy, 20142, Italy
Unknown Facility
Monza, Lombardy, 20052, Italy
Unknown Facility
Rho, Lombardy, 20017, Italy
Unknown Facility
Sondalo, Lombardy, 23039, Italy
Unknown Facility
Sondrio, Lombardy, 23100, Italy
Unknown Facility
Novara, Piedmont, 28100, Italy
Unknown Facility
Catania, Sicily, 95100, Italy
Unknown Facility
Ancona, The Marches, 60121, Italy
Unknown Facility
Pesaro, The Marches, 61122, Italy
Unknown Facility
Lido di Camaiore, Tuscany, 55043, Italy
Unknown Facility
Perugia, Umbria, 06156, Italy
Unknown Facility
Mirano, Veneto, 30035, Italy
Unknown Facility
Padua, Veneto, 35128, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2010
First Posted
March 1, 2010
Study Start
February 1, 2010
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
October 8, 2015
Results First Posted
October 8, 2015
Record last verified: 2015-09