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Sponsored by: |
Hellenic Cooperative Oncology Group |
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Information provided by: | Hellenic Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00783471 |
To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer
Condition | Intervention | Phase |
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Advanced Non-Small Cell Lung Cancer |
Drug: Docetaxel, Erlotinib Drug: Erlotinib, Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Docetaxel Combined With Pulsatile Erlotinib (Tarceva®) In Patients With Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO) |
Estimated Enrollment: | 110 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Docetaxel followed by Erlotinib
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Drug: Docetaxel, Erlotinib
Drug: Docetaxel 75 mg/m2 IV over 30 min on day 1 Drug: Erlotinib 150 mg po daily, days 4-15 Treatment will be repeated every 21 days
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2: Experimental
Erlotinib followed by Docetaxel
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Drug: Erlotinib, Docetaxel
Drug: Erlotinib 150 mg po daily, days 1-12 Drug: Docetaxel 75 mg/m2 IV over 30 min on day 15 Treatment will be repeated every 21 days
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The combination of chemotherapy [such as docetaxel] with continuous administration of targeted drugs which block the molecular machinery of cancer cell growth [such as erlotinib] have failed to improve their efficacy over only-chemotherapy in patients with metastatic lung cancer of the non-small cell histology type. It is not yet known whether administering targeted drugs intermittently could result in improved efficacy of the combinations. This is a multicenter randomized Phase II trial aiming to determine the more active dosing sequence between intermittent erlotinib and docetaxel for treating patients with advanced Non-Small-Lung-Cancer.Patients will be randomly assigned to one of two treatment arms: they will receive a 12-days course of erlotinib either before docetaxel [arm A] or after docetaxel administration [arm B].Treatment will be repeated every 21 days.Patients will be evaluated every 2 cycles (~6 weeks) for response using RECIST criteria. Those patients achieving stable disease or better will continue therapy up to a total 8 cycles. Those patients experiencing progressive disease will be taken off study. Biopsy material will be assessed for biomarkers.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Evangelos Briasoulis | +30 26510 99647 | ebriasou@otenet.gr |
Contact: Nicholas Pavlidis | +30 26510 99394 | npavlid@uoi.gr |
Greece | |
University General Hospital of Ioannina, Medical Oncology Dept | Recruiting |
Ioannina, Greece, 45500 | |
Contact: Evangelos Briasoulis +30 26510 99647 ebriasou@otenet.gr | |
Principal Investigator: Evangelos Briasoulis | |
Hygeia Hospital | Recruiting |
Athens, Greece, 15123 | |
Contact: Paris Kosmidis +30 210 6867105 parkosmi@otenet.gr | |
Principal Investigator: Paris Kosmidis | |
"Papageorgiou" Hospital | Recruiting |
Thessaloniki, Greece, 56403 | |
Contact: George Fountzilas +30 2310 639134 fountzil@auth.gr | |
Principal Investigator: George Fountzilas | |
Metropolitan Hospital, Second Dept of Medical Oncology | Recruiting |
Piraeus, Greece, 18547 | |
Contact: Dimosthenis Skarlos +30 210 4809660 hecogiat@otenet.gr | |
Principal Investigator: Dimosthenis Skarlos | |
Sotiria Hospital | Recruiting |
Athens, Greece, 11526 | |
Contact: Konstantinos Syrigos +30 210 7700220 ksyrigos@med.uoa.gr | |
Principal Investigator: Konstantinos Syrigos |
Principal Investigator: | Evangelos Briasoulis, MD | University of Ioannina Hospital, Medical School |
Responsible Party: | Hellenic Cooperative Oncology Group ( G. Fountzilas/President ) |
Study ID Numbers: | HE 2D/07 |
Study First Received: | October 30, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00783471 |
Health Authority: | Greece: Ethics Committee; Greece: National Organization of Medicines |
Erlotinib Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |