Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Nov 3, 1999

Keywords

ClinConnect Summary

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 non-beta-islet cell tumor cause death. The present study proposes to continue to test the effect of combined chemotherapy with streptozotocin, 5-fluorouracil and doxorubicin in biopsy-proven cases of metastatic non-beta-islet cell tumor in patients with Zollinger-Ellison syndrome. We published our initial experience with this protocol in 1988. An objective response was observed in 40% of patients.

Gender

ALL

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.