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
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab [Avastin]
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 86
- Primary Endpoint
- Percentage of Participants Alive and Without Progressive Disease at Month 6
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Arms & Interventions
1
Intervention: bevacizumab [Avastin]
1
Intervention: gemcitabine
2
Intervention: bevacizumab [Avastin]
2
Intervention: cisplatin
2
Intervention: gemcitabine
Outcomes
Primary Outcomes
Percentage of Participants Alive and Without Progressive Disease at Month 6
Time Frame: 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.
Secondary Outcomes
- 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))
- Percentage of Participants Alive at 12 Months After Randomization(1 year)
- Overall Survival (OS)(From randomization to death or end of the study (up to 53 months))
- Percentage of Participants With an Objective Response(Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6)
- Percentage of Participants With Disease Control(Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6)
- Percentage of Participants by Best Overall Response(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))
- Duration of Response (DoR)(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 Who Died(From randomization to death or end of the study (up to 53 months))