Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas
Completed · Phase 2
Conditions studied: Islet Cell Adenoma, Neoplasm Metastasis, Zollinger Ellison Syndrome
In brief
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 tumors. Prior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers. Because of such effective drugs to treat the ulcers it is more common to see patients dying due to the pancreatic tumors. The study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin.
Key facts
- Study ID
- NCT00001165
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 999
- Starts
- 1978-09-01
- Expected to finish
- 2003-08-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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