Phase II study: Treatment with the drug docetaxel and oxaliplatin for patients who have a confirmed metastatic or locally advanced cancer of the pancreas and in whom initial therapy has failed.

Conditions: advanced metastatic pancreatic cancer
MedDRA version: 14.1Level: LLTClassification code 10033576Term: Pancreas carcinomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2005-004236-40-DE

Lead Sponsor: niversitätsklinikum Ulm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

Dated and signed informed consent

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 of age

Karnofsky index > 60%

Expected live span > 12 weeks

Sufficient bone marrow reserve:
- Granulocytes >= 1.5 x 109/L
- Platlets >= 100 x 109/L
- Hemoglobin >=9g/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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
;
Dated and signed informed consent

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.

Age > 18 years of age

Karnofsky index > 60%

Expected live span > 12 weeks

Sufficient bone marrow reserve:
- Granulocytes >= 1.5 x 109/L
- Platlets >= 100 x 109/L
- Hemoglobin >=9g/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 metastases

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

;
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.