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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Zollinger Ellison Syndrome; Islet Cell Adenoma; Neoplasm Metastasis

Treatments: Drug: combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00001165

78-DK-0133

780133

Details and patient eligibility

About

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.

Full 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 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.