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Sponsored by: |
Philipps University Marburg Medical Center |
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Information provided by: | Philipps University Marburg Medical Center |
ClinicalTrials.gov Identifier: | NCT00395252 |
This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.
Condition | Intervention | Phase |
---|---|---|
Adenocarcinoma |
Drug: Cetuximab (Erbitux®) and Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Multicenter Phase II-Trial to Investigate Safety and Efficacy of an Adjuvant Therapy With Gemcitabine and Erbitux® in Patients With R0 or R1 Resected Pancreatic Cancer |
Estimated Enrollment: | 73 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | January 2010 |
Cetuximab:
Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly for up to 6 months (treatment duration: 24 weeks)
Gemcitabine:
1000 mg/m2 administered on days 1, 8, 15 Cycles will be repeated on day 29, up to 6 treatment cycles will be administered
Mode of administration:
Intravenous infusion
The available data of the presented studies indicate a possible benefit from adjuvant chemotherapy for patients with resected pancreatic cancer. The optimal therapy regimen has yet to be determined.
Based on the experiences with cetuximab (Erbitux®)and gemcitabine in advanced pancreatic cancer and with gemcitabine as adjuvant therapy, the aim of this study is to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0 or R1-resectable pancreatic cancer and to evaluate if the disease free survival can be increased by the addition of an EGFR-targeted therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susanne Harnisch | +49 6421 - 286 6553 | susanne.harnisch@med.uni-marburg.de |
Germany | |
Klinikum Giessen und Marburg, Standort Marburg | Recruiting |
Marburg, Germany, 35033 | |
Contact: Thomas M Gress, Prof.Dr. med ++49 (0)6421-28-66460 thomas.gress@med.uni-marburg.de | |
Contact: Heiko Fensterer, Dr. med ++49 (0)6421-28-66460 heiko.fensterer@med.uni-marburg.de | |
Principal Investigator: Thomas M Gress, Prof.Dr.med | |
Sub-Investigator: Heiko Fensterer, Dr. | |
Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: Angela Märten, Dr.med +49 6221-5639890 angela.maerten@med.uni-heidelberg.de | |
Principal Investigator: Angela Märten, Dr.med | |
Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg | Not yet recruiting |
Regensburg, Germany, 93042 | |
Contact: Esther Endlicher, Dr.med +49 941-944-70010 esther.endlicher@klinik.uni-regensburg.de | |
Principal Investigator: Esther Endlicher, Dr.med | |
Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH | Recruiting |
Mannheim, Germany, 68167 | |
Contact: Andreas Hochhaus, Prof.Dr.med +49 621-383-2854 hochhaus@uni-hd.de | |
Contact: Marco Niedergethmann, PD, Dr. med +49 621-383-2357 marco.niedergethmann@chir.ma.uni-heidelberg.de | |
Principal Investigator: Andreas Hochhaus, Prof. Dr. med | |
II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München | Not yet recruiting |
Munich, Germany, 81675 | |
Contact: Matthias Ebert, Prof.Dr.med matthias.ebert@lrz.tum.de | |
Principal Investigator: Matthias Ebert, Prof.Dr.med | |
Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel | Recruiting |
Kassel, Germany, 34125 | |
Contact: Jürgen Fass, Prof.Dr. med +49 561-980-3036 fass@klinikum-kassel.de | |
Contact: Bernhard Schupfner, Dr.med 0561-9803036 schupfner@klinikum-kassel.de | |
Principal Investigator: Jürgen Fass, Prof.Dr. med | |
Sub-Investigator: Bernhard Schupfner, Dr.med | |
Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center) | Recruiting |
Fulda, Germany, 36043 | |
Contact: Heinz-Gert Höffkes, Prof. Dr. med +49661-845481 heinz-gert.hoeffkes@klinikum-fulda.de | |
Sub-Investigator: Oliver Ranze, Dr.med | |
Principal Investigator: Heinz-Gert Höffkes, Prof.Dr. | |
Klinik für Innere Medizin II, Klinikum der Universität Jena | Recruiting |
Jena, Germany, 07740 | |
Contact: Klaus Höffken, Prof. Dr. med +49 3641-9324200 UKJ-KIM2@med.uni-jena.de | |
Contact: Udo Lindig, Dr.med +49 3641-9324586 udo.lindig@med.uni-jena.de | |
Principal Investigator: Klaus Höffken, Prof.Dr.med | |
Sub-Investigator: Udo Lindig, Dr.med |
Principal Investigator: | Thomas M Gress, Prof.Dr. med | Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg |
Responsible Party: | Koordiniationszentrum für Klinische Studien ( Carmen Schade-Brittinger ) |
Study ID Numbers: | EUDRACT-No. 2005-005168-94 |
Study First Received: | November 1, 2006 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00395252 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
pancreatic cancer adjuvant chemotherapy phase 2 R0 or R1 resected Adenocarcinoma of the Pancreas |
Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Cetuximab Adjuvants, Immunologic Endocrine System Diseases Immunosuppressive Agents Antiviral Agents Pancrelipase |
Carcinoma Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Neoplasms by Site Therapeutic Uses Gemcitabine Endocrine Gland Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type |
Cetuximab Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |