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 - ATIP

• Conditions: 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: 14.0Level: PTClassification code 10033609Term: Pancreatic carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-005168-94-DE
• Lead Sponsor: Philipps-University of Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-31
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 73

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 <= 2
•Patients without metastasis

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

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)
< 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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified