Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer
NCT ID: NCT00690300
Last Updated: 2010-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
44 participants
INTERVENTIONAL
2008-01-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Docetaxel
75 mg/m2 IV on day 1 of each 22 day cycle
Oxaliplatin
80 mg/m2 IV on day 2 of each 22 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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University Halle-Wittenberg
Principal Investigators
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Thomas Seufferlein, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Halle / Klinik für Innere Medizin I
Locations
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Städtische Kliniken Esslingen
Esslingen am Neckar, Baden-Wurttemberg, Germany
Klinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm Klinik für Innere Medizin I
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum Giessen und Marburg GmbH
Marburg, Hesse, Germany
Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle
Halle, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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EudraCT 2005-004236-40
Identifier Type: -
Identifier Source: secondary_id
I1-GOA-1
Identifier Type: -
Identifier Source: org_study_id
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