Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung Cancer

NCT00755170 | Completed Phase 2

• 1 other identifier: CT/08.18
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 9

Brief Summary

This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer

Conditions

Non Small Cell Lung Cancer

Keywords

Vinorelbine; Bevacizumab; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Response rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes (3)

• Toxicity profile

  Toxicity assessment on each cycle

• Progression free survival

  1 year

• Overall survival

  1 year

Study Arms (1)

1

EXPERIMENTAL

Vinorelbine metronomic + bevacizumab

Drug: Vinorelbine; Drug: Bevacizumab

Interventions

Vinorelbine DRUG

Metronomic vinorelbine (p.o) 30 mg total dose/day, every Monday, Wednesday and Friday of each week, continuously without intervals for the equivalence of 6 cycles maximum

Also known as: Navelbine

1

Bevacizumab DRUG

Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks for 6 cycles maximum followed by Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks until disease progression

Also known as: Avastin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed, metastatic (stage IV) non small cell lung cancer
• One previous platinum based chemotherapy regimen with or without taxanes for metastatic NSCLC
• Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
• Age ≥ 18 years
• Performance status (WHO) 0-2
• Life expectancy of at least 12 weeks
• Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 2.5 upper normal limit in the absence of liver metastases or ≤ 5 upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 upper normal limit)
• Patients must be able to understand the nature of this study
• Written informed consent

You may not qualify if:

• Second primary malignancy, except for non-melanoma skin cancer. Pregnant or lactating women
• Any serious, uncontrolled comorbidity on the investigator's judgment
• Uncontrolled infection
• Any sustained chronic toxicity \> grade 2 according to the NCI CTCAE (version 3.0)
• Brain metastases, except if radiated and asymptomatic
• Radiotherapy within the previous 4 weeks
• Previous radiotherapy to the only measurable lesion
• Proteinuria ≥ 500 mgr of protein daily
• Hemoptysis \> 10 cc per event
• Clinically significant hematemesis
• Centrally located lesion or in contact with major vessels
• Pulmonary lesion with cavitation
• Documented hemorrhagic diathesis or coagulation disorder
• Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF \< normal, ventricular arrhythmia, uncontrolled hypertension)
• Thrombotic event within the previous 6 months

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (9)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vinorelbine; Bevacizumab

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)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sofia Agelaki, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

GR (9)