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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carmen Schade-Brittinger, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00395252
First received: November 1, 2006
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Adenocarcinoma
Drug: Cetuximab (Erbitux®) and Gemcitabine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 18 months after registration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: n.a ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: n.a ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: 19 months since registration ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: October 2006
Study Completion Date: January 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one arm study
Gemcitabine and Erbitux treatment
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

Other Names:
  • Cetuximab
  • Gemzar

Detailed Description:

The available data of the presented studies indicate 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 is 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395252

Locations
Germany
Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)
Fulda, Germany, 36043
Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Klinik für Innere Medizin II, Klinikum der Universität Jena
Jena, Germany, 07740
Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel
Kassel, Germany, 34125
Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH
Mannheim, Germany, 68167
Klinikum Giessen und Marburg, Standort Marburg
Marburg, Germany, 35033
II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München
Munich, Germany, 81675
Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg
Regensburg, Germany, 93042
Sponsors and Collaborators
Carmen Schade-Brittinger
Investigators
Principal Investigator: Thomas M Gress, Prof.Dr. med Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg
  More Information

No publications provided by Philipps University Marburg Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmen Schade-Brittinger, Philipps University, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00395252     History of Changes
Other Study ID Numbers: EUDRACT-No. 2005-005168-94
Study First Received: November 1, 2006
Last Updated: February 1, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Philipps University Marburg Medical Center:
pancreatic cancer
adjuvant chemotherapy
phase 2
R0 or R1 resected Adenocarcinoma of the Pancreas

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Cetuximab
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014