Status:
UNKNOWN
Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer
Lead Sponsor:
University of Ulm
Conditions:
Pancreas Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 fir...
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 Fluorourac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00690300
Start Date
January 1 2008
End Date
December 1 2010
Last Update
March 3 2010
Active Locations (5)
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1
Städtische Kliniken Esslingen
Esslingen am Neckar, Baden-Wurttemberg, Germany, 73730
2
Klinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, Germany, 73557
3
Universitätsklinikum Ulm Klinik für Innere Medizin I
Ulm, Baden-Wurttemberg, Germany, 89081
4
Universitätsklinikum Giessen und Marburg GmbH
Marburg, Hesse, Germany, 35043