Pancreatic ductal adenocarcinoma, non resectable MedDRA version: 9.1 Level: LLT Classification code 10033600 Term: Pancreatic adenocarcinoma non-resectable
Conditions
Interventions
Product Name: Sulfasalazine
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: SULFASALAZINE
CAS Number: 599791
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Universitätsklinikum Schleswig-Holstein
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female adult patient, age >18 years Women of childbearing potential must have a negative pregnancy test prior to enrollment and be willing to use appropiate contraception during the entire trial Histologically diagnosed advanced non resectable pancreatic ductal adenocarcinoma Presence of a two-dimensional measurable tumor lesion Expected survival time > 12 weeks Haemoglobin = 9 g/dl White Blood Cell Count > 3500/µl Platelet count > 100.000/µl Total number of granulocytes > 1000/µl Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Other malignant diseases Chemo- or radiotherapy prior to enrollment History of hypersensitivity to sulfonamides, salicylates or gemcitabine or any of the addivites used in the study drugs Immunsuppressed or HIV-seropositive patients Clinically important infection Psychiatric disease Porphyria Impaires hepatic or renal function Hepatitis History of alcohol or drug abuse Ileus Erythema exsudativum multiforme Glucose-6-phosphate-dehydrogenase-deficiency Bronchial asthma Concomitant treatment with ampicilline, neomycine, rifampicin, ethambutol, hexamethylentetramin, cholestyramine, colestipol, methotrexate, sulfonylurea, iron , phenylbutazone or Sulfinpyrazone Inability of taking part in planned study visits Pregnant or nursing women Participation in other clinical trials during the last 4 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the feasibility and safety of combined Sulfasalazine/Gemcitabine treatment. The primary parameter is: Number of treatment days defined as the number of days from the first dose of Sulfasalazine to the last dose of either Sulfasalzine or Gemcitabine.;Secondary Objective: To investigate the efficacy of combined Sulfasalazine / Gemcitabine treatment. The secondary parameters are: Complete remission time, defined as the number of days from the documented start of complete remission to observed progression of disease. Survival time, defined as number of days from the first dose of Gemcitabine to date of death. Progressionfree time, definined as the number of days from the first dose of Gemcitabine to documented progression of disease;Primary end point(s): Number of treatment days defined as the number of days from the first dose of Sulfasalazine to the last dose of either Sulfasalzine or Gemcitabine. Patients will be discontinued from the trial for safety, feasibility and/or ethical reasons. Feasibility and safety reasons are: Progression of tumor Inaceptable toxic reaction (CTCAE Grade 4) Safety and ethical reasons are : Withdrawal of informed consent More beneficial treatment available, desicion taken by responsible physician Presence of exclusion criteria | — |
Countries
Germany
Outcome results
None listed