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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2005-004236-40 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75 mg/m2 IV on day 1 of each 22 day cycle |
| |
| Oxaliplatin | Drug | 80 mg/m2 IV on day 2 of each 22 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor response | 12/2009 and end of the study 12/2010 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Seufferlein, Prof. Dr. | Contact | 49-345-5572661 | thomas.seufferlein@medizin.uni-halle.de | |
| Goetz von Wichert, PD Dr. | Contact | 49-731-500-44748 | goetz.wichert@uniklinik-ulm.de |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Seufferlein, Prof. Dr. | Universitätsklinikum Halle / Klinik für Innere Medizin I | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Städtische Kliniken Esslingen | Recruiting | Esslingen am Neckar | Baden-Wurttemberg | 73730 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26772812 | Derived | 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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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| 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 |
| Klinikum Schwäbisch Gmünd | Recruiting | Mutlangen | Baden-Wurttemberg | 73557 | Germany |
|
| Universitätsklinikum Ulm Klinik für Innere Medizin I | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
|
| Universitätsklinikum Giessen und Marburg GmbH | Recruiting | Marburg | Hesse | 35043 | Germany |
|
| Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle | Recruiting | Halle | 06097 | Germany |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |