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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: | NCT00684099 |
This trial will determine the maximum tolerated dose the recommended phase II dose and the efficacy of this combination in locally advanced or metastatic NSCLC patients
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: Docetaxel Drug: Pemetrexed |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC |
Estimated Enrollment: | 70 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Docetaxel
Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
Drug: Pemetrexed
Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
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Docetaxel as single-agent therapy (100 mg/m2 and 75 mg/m2, every 3 weeks) produces response rates of 26% to 54%. Docetaxel has proven superior compared to best supportive care (BSC) in chemotherapy-naïve as well as in platinum pretreated patients. In addition, docetaxel is active in cisplatin refractory or resistant patients, producing responses ranging from 18% to 25%, implying a lack of cross-resistance between docetaxel and cisplatin, probably due to their different mechanisms of action. Furthermore, docetaxel is associated with significant prolongation of survival when administered as second line therapy, in pretreated patients with advanced NSCLC. Phase II studies of pemetrexed in previously untreated patients with NSCLC have demonstrated single agent response rates of 17% to 23%. A phase II study of pemetrexed in patients with advanced NSCLC, who had progressed during or within 3 months of completing first-line chemotherapy, demonstrated a response rate of 8.9% and median survival time of 5.7 months. Multivariate analysis established an association between an increased risk of severe pemetrexed toxicity and elevated homocysteine (folate and/or B12 vitamin deficiency marker) levels. Since December 1999, all pemetrexed-treated patients are required to receive folic acid and Vitamin B12. A recently reported phase III study compared pemetrexed with docetaxel as 2nd line therapy in patients with advanced NSCLC. Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel.
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 | 30-28-1039-2570 | dorachat@med.uoc.gr |
Contact: Eva Maragkoudaki | 30-28-1039-2857 | dorachat@med.uoc.gr |
Greece | |
"IASO" General Hospital of Athnes, Dep of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD 30-21-0644-2666 secretary@horg.gr | |
Contact: Spyros Georgiadis 30-21-0645-7968 secretary@horg.gr | |
Principal Investigator: Stelios Giassas, MD | |
Air Forces Military Hospital, 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: Nikos Kentepozidis, MD | |
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 | |
"Theagenion" Anticancer Hospital of Thessaloniki | 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 Mpoukovinas, 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 | |
Sotiria" General Hospital, 1st Dep of Pulmonary Diseases | 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: Athina Agelidou, MD | |
"Diabalkaniko" Hospital of Thessaloniki | 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: Christos Emmanouilidis, MD | |
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | 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: Maria Agelidou, m | |
Principal Investigator: Vassilis Xandrinos, MD |
Principal Investigator: | Vassilis Georgoulias, MD | University Hospital of Crete |
Principal Investigator: | Athanasios Kotsakis, MD | University Hospital of Crete |
Responsible Party: | University Hospital of Crete ( V.Georgoulias ) |
Study ID Numbers: | CT/05.18 |
Study First Received: | May 22, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00684099 History of Changes |
Health Authority: | Greece: National Organization of Medicines |
NSCLC Pemetrexed Docetaxel |
Thoracic Neoplasms Antimetabolites Folic Acid Antagonists Carcinoma Docetaxel Pemetrexed Folic Acid |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Carcinoma |
Docetaxel Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |