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Sponsors and Collaborators: |
Hellenic Oncology Research Group University Hospital of Crete |
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Information provided by: | Hellenic Oncology Research Group |
ClinicalTrials.gov Identifier: | NCT00620971 |
This trial will evaluate whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival advantage in patients with locally advanced or metastatic NSCLC.
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: Vinorelbine Drug: Cisplatin Drug: Bevacizumab Drug: Docetaxel Drug: Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer |
Estimated Enrollment: | 350 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
NC/Avastin->DG/Avastin
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Drug: Vinorelbine
Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
Drug: Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
Drug: Gemcitabine
Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
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2: Experimental
DG/Avastin
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Drug: Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
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An unanswered question in first line treatment of non small cell lung cancer (NSCLC) is whether the administration of more than 2 active drugs provides greater efficacy than a two-drug combination. Docetaxel/gemcitabine combination is a well tolerated regimen, which has comparable efficacy to docetaxel/cisplatin or vinorelbine/cisplatin. In a recent phase II study in first line treatment of advanced or metastatic NSCLC, the sequential administration of vinorelbine/cisplatin followed by docetaxel/gemcitabine produced a response rate of 45.8% and a 1-year survival rate of 51%. The addition of bevacizumab to a platinum-based regimen provided a survival benefit in patients with advanced or metastatic NSCLC.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
No previous chemotherapy or immunotherapy for advanced/metastatic NSCLC is allowed
Exclusion Criteria:
Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
Contact: Eva Maragkoudaki | +302810392857 | dorachat@med.uoc.gr |
Greece | |
IASO" General Hospital of Athens, 1st Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106442666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Giassas, MD | |
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Athina Aggelidou, MD | |
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Maria Aggelidou, MD | |
Principal Investigator: Vassilis Xandrinos, MD | |
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Aris Polyzos, MD | |
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Ziras, MD | |
401 Military Hospital, Medical Oncology Unit | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Charalambos Christophillakis, MD | |
Air Forces Military Hospital, Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Kentepozidis, MD | |
University General Hospital of Alexandroupolis, Dep of Medical Oncology | Recruiting |
Alexandroupolis, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Kakolyris, MD | |
"Theagenion" Anticancer Hospital of Thessaloniki | Recruiting |
Thessaloniki, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Ioannis Boukovinas, MD |
Principal Investigator: | Vassilis Georgoulias, MD | University Hospital of Crete, Dep of Medical Oncology |
Responsible Party: | Hellenic Oncology Research Group ( V.Georgoulias ) |
Study ID Numbers: | CT/07.19 |
Study First Received: | January 31, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00620971 History of Changes |
Health Authority: | Greece: National Organization of Medicines |
Non Small Cell Lung Cancer Cisplatin VInorelbine |
Docetaxel Gemcitabine Bevacizumab |
Antimetabolites Thoracic Neoplasms Immunologic Factors Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Carcinoma Docetaxel Vinorelbine |
Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Docetaxel Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Vinorelbine Radiation-Sensitizing Agents |