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

Adenocarcinoma Clinical Trial

— ATIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395252
• Other study ID #: EUDRACT-No. 2005-005168-94
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2006
• Last updated: October 1, 2015
• Start date: October 2006
• Est. completion date: January 2012

Study information

• Verified date: October 2015
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• Cetuximab (Erbitux®) and Gemcitabine
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

Locations

Country	Name	City	State
Germany	Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)	Fulda
Germany	Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg	Heidelberg
Germany	Klinik für Innere Medizin II, Klinikum der Universität Jena	Jena
Germany	Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel	Kassel
Germany	Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH	Mannheim
Germany	Klinikum Giessen und Marburg, Standort Marburg	Marburg
Germany	II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München	Munich
Germany	Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Carmen Schade-Brittinger

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Fensterer H, Schade-Brittinger C, Müller HH, Tebbe S, Fass J, Lindig U, Settmacher U, Schmidt WE, Märten A, Ebert MP, Kornmann M, Hofheinz R, Endlicher E, Brendel C, Barth PJ, Bartsch DK, Michl P, Gress TM; Arbeitsgemeinschaft Internistische Onkologie. Mu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		18 months after registration	Yes
Secondary	Overall survival		n.a	No
Secondary	Quality of life		n.a	No
Secondary	Incidence of Adverse Events		19 months since registration	Yes