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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

Phase 2
18 Years
Not Enrolling

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival

Outcome Time Frame:

18 months after registration

Safety Issue:


Principal Investigator

Thomas M Gress, Prof.Dr. med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EUDRACT-No. 2005-005168-94



Start Date:

October 2006

Completion Date:

January 2012

Related Keywords:

  • Adenocarcinoma
  • pancreatic cancer
  • adjuvant chemotherapy
  • phase 2
  • R0 or R1 resected Adenocarcinoma of the Pancreas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms