Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

Sponsor

University of Ulm (Other)

Overall Status

Unknown status

CT.gov ID

NCT00690300

Collaborator

(none)

Enrollment

Locations

Duration (Months)

8.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Neoplasms	Drug: Docetaxel Drug: Oxaliplatin	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Outcome Measures

Primary Outcome Measures

tumor response [12/2009 and end of the study 12/2010]

Secondary Outcome Measures

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 [every week]
all adverse events will be documented every week with their correlation to Oxaliplatin and Docetaxel

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Städtische Kliniken Esslingen	Esslingen	Baden Württemberg	Germany	73730
2	Klinikum Schwäbisch Gmünd	Mutlangen	Baden Württemberg	Germany	73557
3	Universitätsklinikum Ulm Klinik für Innere Medizin I	Ulm	Baden Württemberg	Germany	89081
4	Universitätsklinikum Giessen und Marburg GmbH	Marburg	Hessen	Germany	35043
5	Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle	Halle		Germany	06097