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Clinical Trials/EUCTR2006-005104-14-DE
EUCTR2006-005104-14-DE
Active, Not Recruiting
N/A

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 enrollmentJune 20, 2007
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ConditionsPancreatic ductal adenocarcinoma, non resectableMedDRA version: 9.1Level: LLTClassification code 10033600Term: Pancreatic adenocarcinoma non-resectable

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pancreatic ductal adenocarcinoma, non resectable
Sponsor
niversitätsklinikum Schleswig-Holstein
Enrollment
20
Status
Active, Not Recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 20, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitätsklinikum Schleswig-Holstein

Eligibility 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 \< 2 mg/dl

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

Outcomes

Primary Outcomes

Not specified

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