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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Adenocarcinoma

Intervention / Treatment
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* Drug: Cetuximab (Erbitux®) and Gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one arm study<br>Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months | Drug: Cetuximab (Erbitux®) and Gemcitabine<br>* 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<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 18 months after registration | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, adjuvant chemotherapy, phase 2, R0 or R1 resected Adenocarcinoma of the Pancreas