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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hellenic Oncology Research Group
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00755170
First received: September 17, 2008
Last updated: June 21, 2014
Last verified: June 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: Toxicity assessment on each cycle ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: November 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755170

Contacts
Contact: Dora Hatzidaki 30-28-1039-2570 dorachat@med@uoc.gr
Contact: Eva Maragkoudaki 30-28-1039-2857 dorachat@med.uoc.gr

Locations
Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology Recruiting
Alexandroupolis, Greece
Contact: Dora Hatzidaki    30-28-1039-2570    dorachat@med.uoc.gr   
Contact: Eva Maragkoudaki    30-28-1039-2857    dorachat@med.uoc.gr   
Principal Investigator: Stelios Kakolyris, MD         
Air Forces Military Hospital of Athens Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    30-21-0644-8666    secretary@horg.gr   
Contact: Spyros Georgiadis    30-28-139-2857    secretary@horg.gr   
Principal Investigator: Nikos Kentepozidis, MD         
401 Military Hospital of Athens Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    30-21-0644-8666    secretary@horg.gr   
Contact: Spyros Georgiadis    30-21-0645-7968    secretary@horg.gr   
Principal Investigator: Charalampos Christophillakis, MD         
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    30-21-0644-8666    secretary@horg.gr   
Contact: Spyros Georgiadis    30-21-0645-7968    secretary@horg.gr   
Principal Investigator: Stelios Giassas, MD         
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    30-21-0644-8666    secretary@horg.gr   
Contact: Spyros Georgiadis    30-21-0645-7968    secretary@horg.gr   
Principal Investigator: Aris Polyzos, MD         
University Hospital of Crete, Dep of Medical Oncology Recruiting
Heraklion, Greece
Contact: Dora Hatzidaki    30-28-1039-2570    dorachat@med.uoc.gr   
Contact: Eva Maragkoudaki    30-28-1039-2857    dorachat@med.uoc.gr   
Sub-Investigator: Zenia Saridaki, MD         
State General Hospital of Larissa, Dep of Medical Oncology Recruiting
Larissa,, Greece
Contact: Nikoleta Karkatzou, MD    30-21-0644-8666    secretary@horg.gr   
Contact: Spyros Georgiadis    30-21-0645-7968    secretary@horg.gr   
Principal Investigator: Athanasios Athanasiadis, MD         
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD    30-21-0644-8666    secretary@horg.gr   
Contact: Spyros Georgiadis    30-21-0645-7968    secretary@horg.gr   
Principal Investigator: Ioannis Boukovinas, MD         
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302106457968    secretary@horg.gr   
Principal Investigator: Christos Emmanouilides, MD         
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

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00755170     History of Changes
Other Study ID Numbers: CT/08.18
Study First Received: September 17, 2008
Last Updated: June 21, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Vinorelbine
Bevacizumab
Chemotherapy

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

ClinicalTrials.gov processed this record on October 22, 2014