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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755170
First Posted: September 18, 2008
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
  Purpose
This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: Vinorelbine Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Combination of Metronomic Vinorelbine and Bevacizumab as 2nd Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: Toxicity assessment on each cycle ]
  • Progression free survival [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]

Enrollment: 48
Study Start Date: November 2008
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vinorelbine metronomic + bevacizumab
Drug: Vinorelbine
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
Other Name: Navelbine
Drug: Bevacizumab
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
Other Name: Avastin

Detailed Description:
Intravenous (IV) vinorelbine is a standard chemotherapy option for the treatment of metastatic NSCLC, either alone or in combination with other agents such as CDDP or Carboplatin with overall response rates (ORR) of 15-35% as 1st line treatment and less than 10% as salvage treatment. For the past few years vinorelbine is available for per os (po) administration with acceptable and reliable pharmacokinetic profiles and with a bioavailability of approximately 40% of the IV dose. In randomized phase II studies IV and po vinorelbine have shown comparable response and overall survival rates. The low dose metronomic chemotherapy that is administered in short intervals has been shown in vitro an in vivo to have antiangiogenic effects. Bevacizumab is a well known anti-angiogenic agent. Recently, a phase III study of 1st line treatment in patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. This study will evaluate the combination of metronomic vinorelbine and bevavizumab as 2nd line treatment of NSCLC.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
  • Concurrent treatment with other anti-cancer drug
  • Major surgical procedure within the previous 4 weeks
  • Serum Να+ < 120mg/dL
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755170


Locations
Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa,, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Sofia Agelaki, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00755170     History of Changes
Other Study ID Numbers: CT/08.18
First Submitted: September 17, 2008
First Posted: September 18, 2008
Last Update Posted: October 4, 2016
Last Verified: October 2016

Keywords provided by Hellenic Oncology Research Group:
Vinorelbine
Bevacizumab
Chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Vinorelbine
Vinblastine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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