Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Ulm.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00690300
First received: June 2, 2008
Last updated: March 2, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.


Condition Intervention Phase
Pancreas Neoplasms
Drug: Docetaxel
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study: Docetaxel Plus Oxaliplatin as Second-line Therapy in Patients With Advanced Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • tumor response [ Time Frame: 12/2009 and end of the study 12/2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 12/2009 and end of study 12/2010 ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 12/2009 and end of study 12/2010 ] [ Designated as safety issue: No ]
  • Questionnaire for quality of life [ Time Frame: every three weeks ] [ Designated as safety issue: No ]
  • Questionnaire for clinical Benefit [ Time Frame: every week ] [ Designated as safety issue: No ]
  • toxicity / safety [ Time Frame: every week ] [ Designated as safety issue: Yes ]
    all adverse events will be documented every week with their correlation to Oxaliplatin and Docetaxel


Estimated Enrollment: 44
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel
    75 mg/m2 IV on day 1 of each 22 day cycle
    Other Name: Taxotere
    Drug: Oxaliplatin
    80 mg/m2 IV on day 2 of each 22 day cycle
    Other Name: Eloxatin
Detailed Description:

For years Fluorouracil was the established treatment for pancreatic cancer with median survival times up to 8 months. Since 1997 Gemcitabine is also a standard therapy with in comparison to Fluorouracil a significant better clinical benefit.

But after progression of the disease under a palliative first-line therapy there is no established second line therapy for pancreatic cancer.

So the purpose of this study is to test the combination of Oxaliplatin and Docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy to get a reasonable second line concept.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dated and signed informed concent
  • Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV)
  • Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy
  • Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity
  • Age >= 18 years
  • Karnofsky index > 60%
  • Expected live span > 12 weeks
  • Sufficient bone marrow reserve: Granulocytes >= 1.5 x 109/L and Platelets >= 100 x 109/L and Hemoglobin >= 9 g/L
  • Serum Bilirubin < 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed)
  • AST/ALT < 2.5 x upper normal limit

Exclusion Criteria:

  • Every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. Inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible
  • Pregnancy or lactation
  • Patients able to reproduce that do not adhere to strict contraception
  • Presence of brain metastasis
  • Severe, uncontrolled infection
  • Preexisting peripheral neuropathy > grade I
  • Preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia
  • Justified disbelief in the compliance of the patient
  • Parallel participation in another clinical trial
  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: NCT00690300

Contacts
Contact: Thomas Seufferlein, Prof. Dr. 49-345-5572661 thomas.seufferlein@medizin.uni-halle.de
Contact: Goetz von Wichert, PD Dr. 49-731-500-44748 goetz.wichert@uniklinik-ulm.de

Locations
Germany
Städtische Kliniken Esslingen Recruiting
Esslingen, Baden Württemberg, Germany, 73730
Contact: Michael Geissler, Prof. Dr.    49-711-3103-2451    m.geissler@kliniken-es.de   
Principal Investigator: Michael Geissler, Prof. Dr.         
Sub-Investigator: Caroline Hoerner, Dr.         
Sub-Investigator: Michael Klausner, Dr.         
Sub-Investigator: Christoph Winkler, Dr.         
Sub-Investigator: Hartmut Mahrhofer, Dr.         
Klinikum Schwäbisch Gmünd Recruiting
Mutlangen, Baden Württemberg, Germany, 73557
Contact: Holger Hebart, Prof. Dr.       holger.hebart@klinikum.sgd.de   
Principal Investigator: Holger Hebart, Prof. Dr.         
Sub-Investigator: Wolfgang Grimminger, Dr.         
Universitätsklinikum Ulm Klinik für Innere Medizin I Recruiting
Ulm, Baden Württemberg, Germany, 89081
Contact: Goetz von Wichert, PD Dr.    49-731-500-44748    goetz.wichert@uniklinik-ulm.de   
Contact: Jochen Klaus, Dr.    49-731-500-44727    jochen.klaus@uniklinik-ulm.de   
Principal Investigator: Goetz von Wichert, PD Dr.         
Sub-Investigator: Sven Walter, Dr.         
Sub-Investigator: Jochen Klaus, Dr.         
Sub-Investigator: Nadine Schulte, Dr. med.         
Universitätsklinikum Giessen und Marburg GmbH Recruiting
Marburg, Hessen, Germany, 35043
Contact: Heiko Fensterer, Dr.    49-6421-286-6460    heiko.fensterer@med.uni-marburg.de   
Principal Investigator: Heiko Fensterer, Dr.         
Sub-Investigator: Patrick Michl, PD Dr.         
Sub-Investigator: Daniela Mueller, Dr.         
Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle Recruiting
Halle, Germany, 06097
Contact: Thomas Seufferlein, Prof. Dr.    + 49 345 557 2661    thomas.seufferlein@medizin.uni-halle.de   
Principal Investigator: Thomas Seufferlein, Prof. Dr.         
Sub-Investigator: Petra Büchner-Steudel, Dr. med.         
Sub-Investigator: Marc Porzner, Dr. med.         
Sub-Investigator: Philipp Thermann, Dr. med.         
Sub-Investigator: Alexander Zipprich, Dr. med.         
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Thomas Seufferlein, Prof. Dr. Universitätsklinikum Halle / Klinik für Innere Medizin I
  More Information

No publications provided

Responsible Party: Prof. Dr. Thomas Seufferlein, University Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00690300     History of Changes
Other Study ID Numbers: I1-GOA-1, EudraCT 2005-004236-40
Study First Received: June 2, 2008
Last Updated: March 2, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
adenocarcinoma of the pancreas
pancreatic cancer
pancreas carcinoma
advanced pancreatic cancer
metastatic pancreatic cancer
second line
palliative
Oxaliplatin
Docetaxel
Taxotere
Eloxatin
Cancer of pancreas
Pancreas cancer

Additional relevant MeSH terms:
Pancreatic Diseases
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Oxaliplatin
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 08, 2014