Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreas Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

tumor response

Outcome Time Frame:

12/2009 and end of the study 12/2010

Safety Issue:

Yes

Principal Investigator

Thomas Seufferlein, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universit├Ątsklinikum Halle / Klinik f├╝r Innere Medizin I

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

I1-GOA-1

NCT ID:

NCT00690300

Start Date:

January 2008

Completion Date:

December 2010

Related Keywords:

  • Pancreas Neoplasms
  • 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
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location