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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: | NCT00681876 |
This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Irinotecan Drug: Avastin Drug: Erbitux |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin |
Estimated Enrollment: | 50 |
Study Start Date: | April 2008 |
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
Irinotecan+Avastin+Erbitux
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Drug: Irinotecan
Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
Drug: Avastin
Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
Drug: Erbitux
Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression
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Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN
Ages Eligible for Study: | 18 Years to 72 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 | |
University General Hospital of Alexandroupolis, Dep of Medical Oncology | Recruiting |
Alexandroupolis, Greece | |
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr | |
Principal Investigator: Stelios Kakolyris, MD | |
State General Hospital of Larissa | Recruiting |
Larissa, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Athanasios Athanasiadis, MD | |
Air Forces Military Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis, MD +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Kentepozidis, MD | |
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | Recruiting |
Thessaloniki, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Ioannis Boukovinas, MD | |
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology | Recruiting |
Piraeus, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Ziras, 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 | |
401 Military Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Charalampos Christophillakis, MD |
Principal Investigator: | John Souglakos, MD | University Hospital of Crete |
Responsible Party: | Hellenic Oncology Research Group ( J.Sougklakos ) |
Study ID Numbers: | CT/05.32 |
Study First Received: | May 19, 2008 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00681876 |
Health Authority: | Greece: National Organization of Medicines |
Metastatic colorectal cancer Second line Irinotecan Erbitux (Cetuximab) Avastin (Bevacizumab) |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Cetuximab Disease Progression Bevacizumab |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Antineoplastic Agents, Phytogenic |