Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung Cancer
This study is currently recruiting participants.
Verified September 2012 by Hellenic Oncology Research Group
Sponsor:
Hellenic Oncology Research Group
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: September 27, 2012
Last verified: September 2012
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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: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (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
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 | |
| 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 | |
| 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 | |
| "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 | |
| "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 | |
| 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: | September 27, 2012 |
| 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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Vinorelbine Vinblastine Bevacizumab |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013