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CompletedNCT00395252ATIPUpdated Oct 2, 2015

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

A Phase 2 interventional study of Cetuximab (Erbitux®) and Gemcitabine in Adenocarcinoma, sponsored by Carmen Schade-Brittinger. Completed at 8 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by Carmen Schade-Brittinger · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Adenocarcinoma

Keywords

  • pancreatic cancer
  • adjuvant chemotherapy
  • phase 2
  • R0 or R1 resected Adenocarcinoma of the Pancreas
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 76 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Carmen Schade-Brittinger is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    one arm study

    Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months

    Drug: Cetuximab (Erbitux®) and Gemcitabine

Interventions

  • DrugCetuximab (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

    Also known as: Cetuximab, Gemzar

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What researchers measure

Primary outcomes

  1. disease free survival

    Time frame: 18 months after registration

Secondary outcomes

  1. Overall survival

  2. Quality of life

  3. Incidence of Adverse Events

    Time frame: 19 months since registration

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Study locations

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

Publications

  • Fensterer H, Schade-Brittinger C, Muller HH, Tebbe S, Fass J, Lindig U, Settmacher U, Schmidt WE, Marten A, Ebert MP, Kornmann M, Hofheinz R, Endlicher E, Brendel C, Barth PJ, Bartsch DK, Michl P, Gress TM; Arbeitsgemeinschaft Internistische Onkologie (AIO). Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP). Ann Oncol. 2013 Oct;24(10):2576-2581. doi: 10.1093/annonc/mdt270. Epub 2013 Jul 29. PubMed 23897705 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00395252
Lead sponsor
Carmen Schade-Brittinger
Responsible party
Carmen Schade-Brittinger (Philipps University, Philipps University Marburg) — Sponsor-investigator
First posted
Nov 2, 2006
Start date
Oct 2006
Primary completion
Nov 2010
Completion
Jan 2012
Last update
Oct 2, 2015

Study contacts

Thomas M Gress, Prof.Dr. med
principal investigator · Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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