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Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

Primary Purpose

Pancreas Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Docetaxel
Oxaliplatin
Sponsored by
University of Ulm
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Neoplasms focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Städtische Kliniken EsslingenRecruiting
  • Klinikum Schwäbisch GmündRecruiting
  • Universitätsklinikum Ulm Klinik für Innere Medizin IRecruiting
  • Universitätsklinikum Giessen und Marburg GmbHRecruiting
  • Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum HalleRecruiting

Outcomes

Primary Outcome Measures

tumor response

Secondary Outcome Measures

progression free survival
overall survival
Questionnaire for quality of life
Questionnaire for clinical Benefit
toxicity / safety
all adverse events will be documented every week with their correlation to Oxaliplatin and Docetaxel

Full Information

First Posted
June 2, 2008
Last Updated
March 2, 2010
Sponsor
University of Ulm
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1. Study Identification

Unique Protocol Identification Number
NCT00690300
Brief Title
Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer
Official Title
Phase II Study: Docetaxel Plus Oxaliplatin as Second-line Therapy in Patients With Advanced Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ulm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Neoplasms
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
75 mg/m2 IV on day 1 of each 22 day cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
80 mg/m2 IV on day 2 of each 22 day cycle
Primary Outcome Measure Information:
Title
tumor response
Time Frame
12/2009 and end of the study 12/2010
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
12/2009 and end of study 12/2010
Title
overall survival
Time Frame
12/2009 and end of study 12/2010
Title
Questionnaire for quality of life
Time Frame
every three weeks
Title
Questionnaire for clinical Benefit
Time Frame
every week
Title
toxicity / safety
Description
all adverse events will be documented every week with their correlation to Oxaliplatin and Docetaxel
Time Frame
every week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Seufferlein, Prof. Dr.
Phone
49-345-5572661
Email
thomas.seufferlein@medizin.uni-halle.de
First Name & Middle Initial & Last Name or Official Title & Degree
Goetz von Wichert, PD Dr.
Phone
49-731-500-44748
Email
goetz.wichert@uniklinik-ulm.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Seufferlein, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Halle / Klinik für Innere Medizin I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Städtische Kliniken Esslingen
City
Esslingen
State/Province
Baden Württemberg
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Geissler, Prof. Dr.
Phone
49-711-3103-2451
Email
m.geissler@kliniken-es.de
First Name & Middle Initial & Last Name & Degree
Michael Geissler, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Caroline Hoerner, Dr.
First Name & Middle Initial & Last Name & Degree
Michael Klausner, Dr.
First Name & Middle Initial & Last Name & Degree
Christoph Winkler, Dr.
First Name & Middle Initial & Last Name & Degree
Hartmut Mahrhofer, Dr.
Facility Name
Klinikum Schwäbisch Gmünd
City
Mutlangen
State/Province
Baden Württemberg
ZIP/Postal Code
73557
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Hebart, Prof. Dr.
Email
holger.hebart@klinikum.sgd.de
First Name & Middle Initial & Last Name & Degree
Holger Hebart, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Wolfgang Grimminger, Dr.
Facility Name
Universitätsklinikum Ulm Klinik für Innere Medizin I
City
Ulm
State/Province
Baden Württemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goetz von Wichert, PD Dr.
Phone
49-731-500-44748
Email
goetz.wichert@uniklinik-ulm.de
First Name & Middle Initial & Last Name & Degree
Jochen Klaus, Dr.
Phone
49-731-500-44727
Email
jochen.klaus@uniklinik-ulm.de
First Name & Middle Initial & Last Name & Degree
Goetz von Wichert, PD Dr.
First Name & Middle Initial & Last Name & Degree
Sven Walter, Dr.
First Name & Middle Initial & Last Name & Degree
Jochen Klaus, Dr.
First Name & Middle Initial & Last Name & Degree
Nadine Schulte, Dr. med.
Facility Name
Universitätsklinikum Giessen und Marburg GmbH
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heiko Fensterer, Dr.
Phone
49-6421-286-6460
Email
heiko.fensterer@med.uni-marburg.de
First Name & Middle Initial & Last Name & Degree
Heiko Fensterer, Dr.
First Name & Middle Initial & Last Name & Degree
Patrick Michl, PD Dr.
First Name & Middle Initial & Last Name & Degree
Daniela Mueller, Dr.
Facility Name
Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle
City
Halle
ZIP/Postal Code
06097
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Seufferlein, Prof. Dr.
Phone
+ 49 345 557 2661
Email
thomas.seufferlein@medizin.uni-halle.de
First Name & Middle Initial & Last Name & Degree
Thomas Seufferlein, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Petra Büchner-Steudel, Dr. med.
First Name & Middle Initial & Last Name & Degree
Marc Porzner, Dr. med.
First Name & Middle Initial & Last Name & Degree
Philipp Thermann, Dr. med.
First Name & Middle Initial & Last Name & Degree
Alexander Zipprich, Dr. med.

12. IPD Sharing Statement

Citations:
PubMed Identifier
26772812
Citation
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.
Results Reference
derived

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Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

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