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

NCT01980472 | Unknown Phase 2

• 1 other identifier: GIDO1201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Rate of grade 3-4 neutropenia defined according to National Cancer Institute Common Terminology Criteria version 4.0 (NCI-CTC v4.0)

  participants will be followed for the duration of the study, around 3 years

Secondary Outcomes (3)

• Plasma VEGF

  participants will be followed for the duration of the study, around 3 years

• Objective response and Stable disease according to RECIST

  participants will be followed for the duration of the study, around 3 years

• progression-free survival and overall survival

  participants will be followed for the duration of the study, around 3 years

Study Arms (1)

bevacizumab, carboplatin and paclitaxel

EXPERIMENTAL

bevacizumab, carboplatin and paclitaxel

Biological: bevacizumab, carboplatin and paclitaxel

Interventions

bevacizumab, carboplatin and paclitaxel BIOLOGICAL

4-6 initial cycles of bevacizumab, carboplatin and paclitaxel bevacizumab until progression or toxicity

bevacizumab, carboplatin and paclitaxel

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Previous chemotherapy for advanced NSCLC.
• 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).
• 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.
• 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 comorbidities \>1 geriatric syndrome

Sponsors & Collaborators

• Grupo de Investigación y Divulgación Oncológica: lead

Study Sites (10)

Hospital Virgen de los Lirios

Alcoy, Valencia, 03804, Spain

Location

Hospital de Castellón

Castellon, Valencia, 12002, Spain

Location

Hospital de Elda

Elda, Valencia, 03600, Spain

Location

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Hospital San Juan

San Juan, Valencia, 03550, Spain

Location

Hospital U. y P. La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Lluis Alcanyis

Xátiva, Valencia, 46800, Spain

Location

Hospital General de Alicante

Alicante, Spain

Location

Hospital General de Valencia

Valencia, Spain

Location

Related Links

• web of Sponsor

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Oscar Juan Vidal, Dr.

  Grup d'investigació i divulgació en oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Chemotherapy Regimen Plus Bevacizumab

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: November 11, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)