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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: | NCT00447967 |
This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer
Condition | Intervention | Phase |
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Gastric Cancer |
Drug: Irinotecan Drug: Oxaliplatin Drug: Fluorouracil Drug: Leucovorin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer |
Estimated Enrollment: | 110 |
Study Start Date: | July 2004 |
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
IOX
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Drug: Irinotecan
Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
Drug: Oxaliplatin
Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
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2: Experimental
FLOX
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Drug: Fluorouracil
Fluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles
Drug: Leucovorin
Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles
Drug: Oxaliplatin
Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles
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There is no regimen considered standard in advanced gastric cancer. The reported response rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable toxicity.
Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a synergistic activity with LOHP in preclinical trials
Ages Eligible for Study: | 18 Years to 75 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 | |
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 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 |
Piraeus, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Ziras, MD | |
"IASO" General Hospital of Athens, 1st Dep 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 | |
401 Military Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Charalampos Christophillakis, MD | |
Air Forces Military Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Kentepozidis, MD | |
State General Hospital of Larissa | Recruiting |
Larissa, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Athanasios Athanasiadis, 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 | |
Greece, Crete | |
University Hospital of Crete | Recruiting |
Heraklion, Crete, Greece, 71110 | |
Contact: Dora Hatzidaki, MD +302810392570 dorachat@med.uoc.gr | |
Contact: Sofia Mavraki +302810392987 maurakh@gmail.com | |
Principal Investigator: Vassilis Georgoulias, MD |
Principal Investigator: | Ioannis Boukovinas, MD | "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology |
Responsible Party: | Hellenic Oncology Research Group ( I.Boukovinas ) |
Study ID Numbers: | CT/04.18 |
Study First Received: | March 14, 2007 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00447967 |
Health Authority: | Greece: National Organization of Medicines |
Metastatic Gastric Cancer Oxaliplatin Irinotecan |
Oxaliplatin Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil |
Stomach Neoplasms Irinotecan Leucovorin Gastrointestinal Neoplasms Stomach cancer |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Antineoplastic Agents, Phytogenic |