NCT01980472

Chemotherapy Plus Bevacizumab in Elderly Non-small Cell Lung Cancer Patients

Phase II Trial of Geriatric Evaluation as Selection Criteria and Predictive Factor of Safety in Elderly Patients (≥ 70 Years) With Non-small Cell Lung Cancer (NSCLC)That Can be Treated With Bevacizumab, Carboplatin and Paclitaxel

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Grupo de Investigación y Divulgación Oncológica · Academic / Other
• Sex: All
• Age: 70 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A phase II Study of an adapted chemotherapy regimen plus bevacizumab in elderly non-small cell lung cancer patients selected by geriatric assessment

Detailed description

CRITERIOS INCLUSION * Written informed consent confirming that the patient understands the study objective and the procedures required. * Patients must be able to accomplish with the study protocol. * Men and women ≥70 years old. * Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC) with EGFR gen mutational status negative or non-determinable. * Patients with stage IV disease. * Patients who have not received first-line treatment * Patients with ECOG performance status 0 or 1. * Adequate bone marrow function, defined as: * Absolute neutrophil count (ANC) ≥1.500/mm3 or ≥1.5x109/L; * Hemoglobin ≥ 9 g/dL. * Platelet count ≥ 100.000/mm3. * Adequate renal function, defined as: * Creatinine clearance ≥ 40 ml/min, according to MDRD formula. * Urine dipstick proteinuria \<2+. If urine dipstick for proteinuria ≥2+ 24 hours urine must be collected within 24 hours, and proteins must be less than 1 g. * Fertile males must use an effective contraceptive method (error rate per year \<1%) during the trial and until 6 months after the last study treatment dose, such as sexual abstinence, previous vasectomy and/or having a partner using any of following methods: implantables, injections, combined oral contraceptives and/or intrauterine device (hormonal only). CRITERIOS EXCLUSION * Previous chemotherapy for advanced NSCLC. * History of haemoptysis grade ≥ 2 (defined as at least 2.5 mL of bright red blood) in the 3 months before inclusion. * Major surgery (including open biopsy), significant traumatic injuries in the 28 days before inclusion or anticipation of the need of major surgical procedure during the treatment period * Minor surgery, including permanent catheter insertion, in the 24 hours before bevacizumab infusion. * Untreated brain metastases. Patients with CNS metastases treated with radiotherapy or surgery may be included if there is no evidence of progression after treatment * Radiological evidence of a tumor that invades or is adjacent to a main blood vessel (e.g. lung artery or superior cava venous). * Radiotherapy, in any lesion and for any reason, within 28 days before inclusion. Palliative radiotherapy for bone lesions within 14 days before inclusion is allowed. * Treatment with aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day) within 10 days prior to bevacizumab first dose. Use of full dose of oral or parenteral anticoagulants or thrombolytic agents in therapeutic doses. Prophylactic use of anticoagulant therapy is allowed. * Uncontrolled hypertension (systolic BP \>140 mmHg, diastolic BP \>90mmHg) in the 28 days previous to inclusion or history of hypertensive crisis, or hypertensive encephalopathy. * Clinically significant cardiovascular disease (i.e. cerebrovascular accident (CVA), myocardial infarction within 6 months prior to inclusion, unstable angina, congestive cardiac insufficiency NYHA ≥ II, left ventricular ejection fraction (LVEF) \<50% or serious cardiac arrhytmia), not responding to treatment or that can interfere with trial treatment administration. * Not healed wounds, active peptic ulcer or untreated bone fracture. * Hypersensibility to any of the active ingredients of the study treatment (bevacizumab, carboplatine and paclitaxel) or any of its excipients. * Serious cognitive impairment that limits the patient to understand and answer the study questionnaires. * Inability to comply with the study protocol and/or follow-up procedures due to psychological, familiar, social or geographical problems * Patients with an ADL score \<5 at the screening. * Patients with dementia: 9-12 points in the Folstein MMS at the screening. * Patients accomplishing fragility Balducci criteria at the screening: * Age ≥ 85 years old * Dependence in 1 or more ADL * \>3 comorbilities * \>1 geriatric syndrome OBJETIVOS To assess the toxicity of the treatment in elderly patients (≥70 years) with NSC lung cancer who meet inclusion criteria for bevacizumab and selected based on a geriatric evaluation. Determine predictive factors of toxicity in the elderly population (≥70 years). Determine objective response rate Determine disease control rate Determine progression free survival Determine overall survival Determine safety of the treatment combination VARIABLES Primary endpoint: Rate of grade 3-4 neutropenia defined according to National Cancer Institute Common Terminology Criteria version 4.0 (NCI-CTC v4.0). Secondary endpoints: * Items of the Comprehensive Geriatric Assessment (CGA) scale as predictive factors for toxicity end-points. * Objective response according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). * Progression-free survival. * Overall survival.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab, carboplatin and paclitaxel	4-6 initial cycles of bevacizumab, carboplatin and paclitaxel bevacizumab until progression or toxicity

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-06-01
• Completion: 2017-08-01
• First posted: 2013-11-11
• Last updated: 2017-02-27

Locations

10 sites across 1 country: Spain