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

Primary Purpose

Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cetuximab (Erbitux®) and Gemcitabine
Sponsored by
Carmen Schade-Brittinger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma focused on measuring pancreatic cancer, adjuvant chemotherapy, phase 2, R0 or R1 resected Adenocarcinoma of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one arm study

Arm Description

Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months

Outcomes

Primary Outcome Measures

disease free survival

Secondary Outcome Measures

Overall survival
Quality of life
Incidence of Adverse Events

Full Information

First Posted
November 1, 2006
Last Updated
October 1, 2015
Sponsor
Carmen Schade-Brittinger
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1. Study Identification

Unique Protocol Identification Number
NCT00395252
Brief Title
Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carmen Schade-Brittinger

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma
Keywords
pancreatic cancer, adjuvant chemotherapy, phase 2, R0 or R1 resected Adenocarcinoma of the Pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
one arm study
Arm Type
Experimental
Arm Description
Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months
Intervention Type
Drug
Intervention Name(s)
Cetuximab (Erbitux®) and Gemcitabine
Other Intervention Name(s)
Cetuximab, Gemzar
Intervention Description
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
Primary Outcome Measure Information:
Title
disease free survival
Time Frame
18 months after registration
Secondary Outcome Measure Information:
Title
Overall survival
Title
Quality of life
Title
Incidence of Adverse Events
Time Frame
19 months since registration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Gress, Prof.Dr. med
Organizational Affiliation
Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinik für Innere Medizin II, Klinikum der Universität Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum Giessen und Marburg, Standort Marburg
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23897705
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.
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Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer

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