advanced metastatic pancreatic cancer MedDRA version: 14.1 Level: LLT Classification code 10033576 Term: Pancreas carcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Eloxatin
Product Name: Eloxatin
Product Code: L01XA03
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Oxaliplatin
CAS Number: 61825-94-3
Concentration unit:
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 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 =65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
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 ;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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective 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, for tumor response after RECIST criteria;Secondary Objective: Progression free survival Overall survival Toxicity Quality of life Clinical benefit ;Primary end point(s): Tumor response ;Timepoint(s) of evaluation of this end point: as soon as the last patient has completed the follow-up period;Main Objective: Primary objective 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, for tumor response after RECIST criteria;Secondary Objective: Progression free survival Overall survival Toxicity Quality of life Clinical benefit ;Primary end point(s): Tumor response ;Timepoint(s) of evaluation of this end point: as soon as the last patient has completed the follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival Overall survival Quality of life Clinical benefit ;Timepoint(s) of evaluation of this end point: as soon as the last patient has competed the follow-up period;Secondary end point(s): Progression free survival Overall survival Quality of life Clinical benefit ;Timepoint(s) of evaluation of this end point: as soon as the last patient has competed the follow-up period | — |
Countries
Germany
Contacts
Public ContactProf. Dr. med. Thomas Seufferlein;Prof. Dr. med. Thomas Seufferlein ;
Universitätsklinikum Ulm;Universitätsklinikum Ulm
Outcome results
None listed