Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study: Docetaxel Plus Oxaliplatin as Second-line Therapy in Patients With Advanced Metastatic Pancreatic Cancer

Conditions
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Pancreas Neoplasms

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|75 mg/m2 IV on day 1 of each 22 day cycle|
|Drug: Oxaliplatin|80 mg/m2 IV on day 2 of each 22 day cycle|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response |  | 12/2009 and end of the study 12/2010 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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