Status:
COMPLETED
Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Islet Cell Adenoma
Neoplasm Metastasis
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumo...
Detailed Description
Heretofore morbidity and risk of death in Zollinger-Ellison syndrome were caused by severe ulcer disease. The advent of specific drugs to cure ulcer disease now extends life until metastases from the ...
Eligibility Criteria
INCLUSION CRITERIA
Subjects selected for this study will be patients with Zollinger-Ellison syndrome who are being evaluated under the protocol entitled "Diagnostic Evaluation of Patients with Suspected Abnormalities of Gastric Secretion" (80-DK-0123).
Histologically proven gastrinoma;
Evidence of metastatic disease or locally invasive tumor by angiography, ultrasound, computerized axial tomography, MRI scan or bone scan;
Progression of the tumor during the preceding 6 months.
EXCLUSION CRITERIA
The following pre-existing conditions will exclude patients from the study:
Congestive heart failure;
Proteinuria greater than 1 gram/day;
Serum creatinine greater than 1.5 mg%;
Platelet count less than 100,000/mm3;
White blood count less than 2500/mm3;
Pregnancy.
Key Trial Info
Start Date :
September 1 1978
Trial Type :
INTERVENTIONAL
End Date :
August 1 2003
Estimated Enrollment :
999 Patients enrolled
Trial Details
Trial ID
NCT00001165
Start Date
September 1 1978
End Date
August 1 2003
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States, 20892