Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

Pancreas Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00690300
• Other study ID #: I1-GOA-1
• Secondary ID: EudraCT 2005-004
• Status: Recruiting
• Phase: Phase 2
• First received: June 2, 2008
• Last updated: March 2, 2010
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2010
• Source: University of Ulm
• Contact: Thomas Seufferlein, Prof. Dr.
• Phone: 49-345-5572661
• Email: thomas.seufferlein[@]medizin.uni-halle.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreas Neoplasms
• Pancreatic Neoplasms

Intervention

Drug:
• Docetaxel
75 mg/m2 IV on day 1 of each 22 day cycle
• Oxaliplatin
80 mg/m2 IV on day 2 of each 22 day cycle

Locations

Country	Name	City	State
Germany	Städtische Kliniken Esslingen	Esslingen	Baden Württemberg
Germany	Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle	Halle
Germany	Universitätsklinikum Giessen und Marburg GmbH	Marburg	Hessen
Germany	Klinikum Schwäbisch Gmünd	Mutlangen	Baden Württemberg
Germany	Universitätsklinikum Ulm Klinik für Innere Medizin I	Ulm	Baden Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response		12/2009 and end of the study 12/2010	Yes
Secondary	progression free survival		12/2009 and end of study 12/2010	No
Secondary	overall survival		12/2009 and end of study 12/2010	No
Secondary	Questionnaire for quality of life		every three weeks	No
Secondary	Questionnaire for clinical Benefit		every week	No
Secondary	toxicity / safety	all adverse events will be documented every week with their correlation to Oxaliplatin and Docetaxel	every week	Yes