Clinical trial NCT00395252: Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma
Keywords: pancreatic cancer
adjuvant chemotherapy
phase 2
R0 or R1 resected Adenocarcinoma of the Pancreas
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2006-11-02
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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 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.

Primary outcomes:
measure: disease free survival
timeFrame: 18 months after registration
Secondary outcomes:
measure: Overall survival
measure: Quality of life
measure: Incidence of Adverse Events
timeFrame: 19 months since registration
Other outcomes:
Locations:
city: Fulda
country: Germany
facility: Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg
city: Jena
country: Germany
facility: Klinik für Innere Medizin II, Klinikum der Universität Jena
city: Kassel
country: Germany
facility: Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel
city: Mannheim
country: Germany
facility: Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH
city: Marburg
country: Germany
facility: Klinikum Giessen und Marburg, Standort Marburg
city: Munich
country: Germany
facility: II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München
city: Regensburg
country: Germany
facility: Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg
Study officials:
affiliation: Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg
name: Thomas M Gress, Prof.Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.