EUCTR2006-005104-14-DEActive, not recruitingNot Applicable
A pilot study to investigate the safety and efficacy of a combined treatment with Gemcitabine and Sulfasalazine in pancreatic ductal adenocarcinoma
niversitätsklinikum Schleswig-Holstein0 sites20 target enrollmentStarted: June 20, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •Impaires hepatic or renal function
- •History of alcohol or drug abuse
- •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
Investigators
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