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

NCT00395252 | Completed Phase 2 DMC

• 1 other identifier: EUDRACT-No. 2005-005168-94
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Adenocarcinoma

Keywords

pancreatic cancer; adjuvant chemotherapy; phase 2; R0 or R1 resected Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

• disease free survival

  18 months after registration

Secondary Outcomes (3)

• Overall survival

• Quality of life

• Incidence of Adverse Events

  19 months since registration

Study Arms (1)

one arm study

EXPERIMENTAL

Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months

Drug: Cetuximab (Erbitux®) and Gemcitabine

Interventions

Cetuximab (Erbitux®) and Gemcitabine 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

Also known as: Cetuximab, Gemzar

one arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmen Schade-Brittinger: lead

Study Sites (8)

Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)

Fulda, 36043, Germany

Location

Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Klinik für Innere Medizin II, Klinikum der Universität Jena

Jena, 07740, Germany

Location

Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel

Kassel, 34125, Germany

Location

Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH

Mannheim, 68167, Germany

Location

Klinikum Giessen und Marburg, Standort Marburg

Marburg, 35033, Germany

Location

II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München

Munich, 81675, Germany

Location

Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg

Regensburg, 93042, Germany

Location

Related Publications (1)

• 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.

  PMID: 23897705 RESULT

MeSH Terms

Conditions

Adenocarcinoma; Pancreatic Neoplasms

Interventions

Cetuximab; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Thomas M Gress, Prof.Dr. med

  Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Philipps University

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 2, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2012
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

DE (8)