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

October 1, 2015 updated by: Carmen Schade-Brittinger

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Fulda, Germany, 36043
        • Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)
      • Heidelberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg
      • Jena, Germany, 07740
        • Klinik für Innere Medizin II, Klinikum der Universität Jena
      • Kassel, Germany, 34125
        • Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel
      • Mannheim, Germany, 68167
        • Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH
      • Marburg, Germany, 35033
        • Klinikum Giessen und Marburg, Standort Marburg
      • Munich, Germany, 81675
        • II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München
      • Regensburg, Germany, 93042
        • Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

Other Names:
  • Gemzar
  • Cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: 18 months after registration
18 months after registration

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Quality of life
Incidence of Adverse Events
Time Frame: 19 months since registration
19 months since registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmen Schade-Brittinger

Investigators

  • Principal Investigator: Thomas M Gress, Prof.Dr. med, Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 1, 2006

First Submitted That Met QC Criteria

November 1, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACT-No. 2005-005168-94

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adenocarcinoma

Clinical Trials on Cetuximab (Erbitux®) and Gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe