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Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer (ATIP)
This study is currently recruiting participants.
Verified by Philipps University Marburg Medical Center, March 2008
First Received: November 1, 2006   Last Updated: March 10, 2008   History of Changes
Sponsored by: Philipps University Marburg Medical Center
Information provided by: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00395252
  Purpose

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

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride Cetuximab
U.S. FDA Resources
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

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Disease-free survival

Secondary Outcome Measures:
  • Overall survival
  • Quality of life
  • Incidence of Adverse Events

Estimated Enrollment: 73
Study Start Date: October 2006
Estimated Study Completion Date: January 2010
Intervention Details:
    Drug: Cetuximab (Erbitux®) and Gemcitabine

    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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provided signed written informed consent.
  • Men and woman age > 18 years
  • Histologically confirmed R0 OR R1 resected ductal adenocarcinoma of the pancreas
  • Life expectancy >12 weeks
  • Patients with performance status of ECOG ≤ 2
  • Patients without metastasis

Exclusion Criteria:

  • Women of child bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and follow-up to 4 weeks after the study.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial).
  • Inadequate hematologic function defined by an absolute neutrophils count (ANC) < 1,500/mm³, a platelet count < 100,000/mm³ and a hemoglobin < 9 g/dL.
  • Inadequate hepatic function defined by the upper limit of normal (ULN), AST and ALT levels > 5 times the ULN.
  • Serum bilirubin > 1.5 times the ULN.
  • Inadequate renal function defined by a serum creatinine > 1.5 times the ULN.
  • Prior cetuximab or other therapy that targets the EGF pathway.
  • Prior antibody therapy.
  • Any known allergic reaction against cetuximab.
  • Any concurrent chronic systemic immune therapy, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agents.
  • HIV infection.
  • Having participated in another clinical trial in the preceding 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395252

Contacts
Contact: Susanne Harnisch +49 6421 - 286 6553 susanne.harnisch@med.uni-marburg.de

Locations
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            
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
Principal Investigator: Thomas M Gress, Prof.Dr. med Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg
  More Information

No publications provided

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

Keywords provided by Philipps University Marburg Medical Center:
pancreatic cancer
adjuvant chemotherapy
phase 2
R0 or R1 resected Adenocarcinoma of the Pancreas

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009