A pilot study to investigate the safety and efficacy of a combined treatment with Gemcitabine and Sulfasalazine in pancreatic ductal adenocarcinoma

Conditions: Pancreatic ductal adenocarcinoma, non resectable
MedDRA version: 9.1Level: LLTClassification code 10033600Term: Pancreatic adenocarcinoma non-resectable

Registration Number: EUCTR2006-005104-14-DE

Lead Sponsor: niversitätsklinikum Schleswig-Holstein

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

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 < 2 mg/dl
Creatinin < 1,5 xULN
ECOG performance status = 2
Written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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