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

NCT ID: NCT00395252

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-01-31

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.

Conditions

Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

one arm study

Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months

Group Type: EXPERIMENTAL

Cetuximab (Erbitux®) and Gemcitabine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Cetuximab; Gemzar

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmen Schade-Brittinger

OTHER

Sponsor Role: lead

Responsible Party

Carmen Schade-Brittinger

Philipps University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas M Gress, Prof.Dr. med

Role: PRINCIPAL_INVESTIGATOR

Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg

Locations

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, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 23897705 (View on PubMed)

Other Identifiers

EUDRACT-No. 2005-005168-94

Identifier Type: -

Identifier Source: org_study_id