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

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.

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Key information

Conditions

Islet Cell Adenoma Adenocarcinoma Adenoma Adenoma, Islet Cell Carcinoma Carcinoma, Islet Cell Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Gastrinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Stomach Diseases Zollinger Ellison Syndrome Zollinger-Ellison Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Official study title

Evaluation of Chemotherapy With Streptozotocin Combined With 5-Fluorouracil and Adriamycin in Patients With Zollinger-Ellison Syndrome and Metastatic Non-Beta-Islet Cell Neoplasm

Important dates

Study start: 1978
Study completion: 2003
First posted: Nov 4, 1999
Registry last updated: Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed