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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: | NCT00440414 |
The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: Erlotinib (Tarceva) Drug: Pemetrexed (Alimta) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 450 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Alimta
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Drug: Pemetrexed (Alimta)
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
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2: Experimental
Tarceva
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Drug: Erlotinib (Tarceva)
Erlotinib at the dose of 150 mg orally once a day continually until progression
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This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
Contact: Sofia Mavraki | +302810392987 | maurakh@gmail.com |
Greece | |
IASO General Hospital of Athens, 1st Department of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 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: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Athina Aggelidou, MD | |
Principal Investigator: Anna Xrhstou, MD | |
Principal Investigator: Ourania Anagnostopoulou, MD | |
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases | Recruiting |
Athens, Greece | |
Contact: George Tavoularis, MD +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Foteini Apostolopoulou, MD | |
Principal Investigator: Vassilis Xandrinos, MD | |
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Recruiting |
Athens, Greece | |
Contact: George Tavoularis, MD +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis, MD +302106457968 secretary@horg.gr | |
Principal Investigator: Aris Polyzos, MD | |
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology | Recruiting |
Piraeus, Greece | |
Contact: George Tavoularis +302106457968 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: George Tavoularis +302106457968 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: George Tavoularis +302106457968 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: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Kakolyris, MD | |
Theagenion Anticancer Hospital of Thessaloniki | Recruiting |
Thessaloniki, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Ioannis Boukovinas, MD |
Principal Investigator: | Lampros Vamvakas, MD | University Hospital of Crete |
Principal Investigator: | Athanasios Karampeazis, MD | University Hospital of Crete |
Responsible Party: | Hellenic Oncology Research Group ( L.Vamvakas ) |
Study ID Numbers: | CT/06.05 |
Study First Received: | February 26, 2007 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00440414 |
Health Authority: | Greece: National Organization of Medicines |
Cancer Non-small-cell lung cancer Chemotherapy Pemetrexed Erlotinib |
Folic Acid Erlotinib Pemetrexed Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |
Folic Acid Antagonists Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |