Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer - Full Text View

Sponsor:	University of Ulm
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00690300

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 II

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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Oxaliplatin Docetaxel

U.S. FDA Resources

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:

75 mg/m2 IV on day 1 of each 22 day cycle

Other Name: Taxotere

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

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:

Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases

Endocrine System Diseases
Oxaliplatin
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012