The aim is to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0-resectable pancreatic cancer and to evaluate if the progression free survival can be increased by the addition of an EGFR-targeted therapy. MedDRA version: 14.0 Level: PT Classification code 10033609 Term: Pancreatic carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Erbitux 5 mg/ml
Product Name: Erbitux
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Current Sponsor code: EMD271786
Other descriptive na
Sponsors
Philipps-University of Marburg
Eligibility
Sex/Gender
All
Inclusion criteria
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 ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 76
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 enrolment 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) 5 times the ULN. • Serum bilirubine > 1.5 times the ULN. • Inadequate renal function defined by a serum creatinine > 1.5 times the ULN. • Prior cetuximab or other therapy which 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to determine the disease-free survival rate at 18 months after start of treatment. Disease-free survival time is defined as the time from start of registration to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last documented efficacy documentation. ;Secondary Objective: The secondary objectives of this study are to assess the following parameters: • Overall survival • treatment related toxicity • Quality of life ;Primary end point(s): To investigate the effects of treatment with cetuximab and gemcitabine on disease-free-survival in patients with R0 or R1-resected adenocarcinoma of the pancreas (adjuvant therapy setting);Timepoint(s) of evaluation of this end point: At the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival • Quality of life • Incidence of Adverse Events ;Timepoint(s) of evaluation of this end point: at the end of study | — |
Countries
Germany
Contacts
Public ContactKKS Marburg
Phillips-Universität Marburg
Outcome results
None listed