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Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer (ATIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395252
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : October 2, 2015
Information provided by (Responsible Party):
Carmen Schade-Brittinger, Philipps University Marburg Medical Center

Brief Summary:
This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Drug: Cetuximab (Erbitux®) and Gemcitabine Phase 2

Detailed Description:

Available study data indicated 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 was 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2006
Actual Primary Completion Date : November 2010
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: one arm study
Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months
Drug: Cetuximab (Erbitux®) and Gemcitabine


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)


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

Other Names:
  • Cetuximab
  • Gemzar

Primary Outcome Measures :
  1. disease free survival [ Time Frame: 18 months after registration ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: n.a ]
  2. Quality of life [ Time Frame: n.a ]
  3. Incidence of Adverse Events [ Time Frame: 19 months since registration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395252

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Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)
Fulda, Germany, 36043
Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Klinik für Innere Medizin II, Klinikum der Universität Jena
Jena, Germany, 07740
Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel
Kassel, Germany, 34125
Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH
Mannheim, Germany, 68167
Klinikum Giessen und Marburg, Standort Marburg
Marburg, Germany, 35033
II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München
Munich, Germany, 81675
Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg
Regensburg, Germany, 93042
Sponsors and Collaborators
Carmen Schade-Brittinger
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Principal Investigator: Thomas M Gress, Prof.Dr. med Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg

Publications of Results:
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Responsible Party: Carmen Schade-Brittinger, Philipps University, Philipps University Marburg Medical Center Identifier: NCT00395252     History of Changes
Other Study ID Numbers: EUDRACT-No. 2005-005168-94
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015
Keywords provided by Carmen Schade-Brittinger, Philipps University Marburg Medical Center:
pancreatic cancer
adjuvant chemotherapy
phase 2
R0 or R1 resected Adenocarcinoma of the Pancreas
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological