Docetaxel Plus Oxaliplatin As Therapy In Patients With Pancreatic Cancer

Study Overview

Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

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.

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.

Pancreas Neoplasms

DRUG: Docetaxel
DRUG: Oxaliplatin

I1-GOA-1
EudraCT 2005-004236-40

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-03-02
First Submitted that Met QC Criteria 2008-06-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-03-03
First Posted (ESTIMATED) 2008-06-04	Results First Posted N/A	Last Verified 2010-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
tumor response		12/2009 and end of the study 12/2010

Secondary Outcome Measures	Measure Description	Time Frame
progression free survival		12/2009 and end of study 12/2010
overall survival		12/2009 and end of study 12/2010
Questionnaire for quality of life		every three weeks
Questionnaire for clinical Benefit		every week
toxicity / safety	all adverse events will be documented every week with their correlation to Oxaliplatin and Docetaxel	every week

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Thomas Seufferlein, Prof. Dr.

Phone Number: 49-345-5572661

Email: thomas.seufferlein@medizin.uni-halle.de

Study Contact Backup

Name: Goetz von Wichert, PD Dr.

Phone Number: 49-731-500-44748

Email: goetz.wichert@uniklinik-ulm.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Thomas Seufferlein, Prof. Dr., Universitätsklinikum Halle / Klinik für Innere Medizin I

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ettrich TJ, Perkhofer L, von Wichert G, Gress TM, Michl P, Hebart HF, Buchner-Steudel P, Geissler M, Muche R, Danner B, Kachele V, Berger AW, Guthle M, Seufferlein T. DocOx (AIO-PK0106): a phase II trial of docetaxel and oxaliplatin as a second line systemic therapy in patients with advanced pancreatic ductal adenocarcinoma. BMC Cancer. 2016 Jan 15;16:21. doi: 10.1186/s12885-016-2052-4.

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Resources

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Clinical Trial Record