Clinical trial NCT00690300: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: 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
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: tumor response
timeFrame: 12/2009 and end of the study 12/2010
Secondary outcomes:
measure: progression free survival
timeFrame: 12/2009 and end of study 12/2010
measure: overall survival
timeFrame: 12/2009 and end of study 12/2010
measure: Questionnaire for quality of life
timeFrame: every three weeks
measure: Questionnaire for clinical Benefit
timeFrame: every week
measure: toxicity / safety
timeFrame: every week
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Städtische Kliniken Esslingen
state: Baden Württemberg
city: Mutlangen
country: Germany
facility: Klinikum Schwäbisch Gmünd
state: Baden Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm Klinik für Innere Medizin I
state: Baden Württemberg
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg GmbH
state: Hessen
city: Halle
country: Germany
facility: Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle
Study officials:
affiliation: Universitätsklinikum Halle / Klinik für Innere Medizin I
name: Thomas Seufferlein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.