Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer
Information source: University of Ulm
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas Neoplasms
Intervention: Docetaxel (Drug); Oxaliplatin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Ulm Official(s) and/or principal investigator(s):
Thomas Seufferlein, Prof. Dr., Principal Investigator, Affiliation: Universitätsklinikum Halle / Klinik für Innere Medizin I
Overall contact:
Thomas Seufferlein, Prof. Dr., Phone: 49-345-5572661, Email: thomas.seufferlein@medizin.uni-halle.de
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.
Clinical Details
Official title: Phase II Study: Docetaxel Plus Oxaliplatin as Second-Line Therapy in Patients With Advanced Metastatic Pancreatic Cancer
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: tumor response
Secondary outcome: progression free survivaloverall survival toxicity Quality of life Clinical Benefit
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Thomas Seufferlein, Prof. Dr., Phone: 49-345-5572661, Email: thomas.seufferlein@medizin.uni-halle.de
Städtische Kliniken Esslingen, Esslingen, Baden Württemberg 73730, Germany; Recruiting
Michael Geissler, Prof. Dr., Phone: 49-711-3103-2451, Email: m.geissler@kliniken-es.de
Michael Geissler, Prof. Dr., Principal Investigator
Caroline Hoerner, Dr., Sub-Investigator
Michael Klausner, Dr., Sub-Investigator
Christoph Winkler, Dr., Sub-Investigator
Hartmut Mahrhofer, Dr., Sub-Investigator
Klinikum Schwäbisch Gmünd, Mutlangen, Baden Württemberg 73557, Germany; Recruiting
Holger Hebart, Prof. Dr., Email: holger.hebart@klinikum.sgd.de
Holger Hebart, Prof. Dr., Principal Investigator
Wolfgang Grimminger, Dr., Sub-Investigator
Universitätsklinikum Ulm Klinik für Innere Medizin I, Ulm, Baden Württemberg 89081, Germany; Recruiting
Goetz von Wichert, PD Dr., Phone: 49-731-500-44748, Email: goetz.wichert@uniklinik-ulm.de
Jochen Klaus, Dr., Phone: 49-731-500-44727, Email: goetz.wichert@uniklinik-ulm.de
Goetz von Wichert, PD Dr., Principal Investigator
Sven Walter, Dr., Sub-Investigator
Jochen Klaus, Dr., Sub-Investigator
Universitätsklinikum Giessen und Marburg GmbH, Marburg, Hessen 35043, Germany; Recruiting
Heiko Fensterer, Dr., Phone: 49-6421-286-6460, Email: heiko.fensterer@med.uni-marburg.de
Heiko Fensterer, Dr., Principal Investigator
Patrick Michl, PD Dr., Sub-Investigator
Daniela Mueller, Dr., Sub-Investigator
Universitätsklinikum Mainz, Mainz, Rheinland Pfalz 55131, Germany; Recruiting
Markus Möhler, PD Dr., Phone: 49-6131-170, Email: moehler@mail.uni-mainz.de
Markus Möhler, PD Dr., Principal Investigator
Peter Galle, Prof. Dr., Sub-Investigator
Martin Goetz, Dr., Sub-Investigator
Henning Schulze-Bergkamen, Dr., Sub-Investigator
Martin Sprinzl, Dr., Sub-Investigator
Andreas Teufel, Dr., Sub-Investigator
Additional Information
Starting date: January 2008
Ending date: December 2009
Last updated: February 12, 2009
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