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

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001165

Purpose

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.

Condition	Intervention	Phase
Islet Cell Adenoma Neoplasm Metastasis Zollinger Ellison Syndrome	Drug: combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Fluorouracil Pancrelipase Ultrase Streptozocin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study
Official 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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	999
Study Start Date:	September 1978
Estimated Study Completion Date:	August 2003

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 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001165

Locations

United States, Maryland
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

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

More Information

Publications:

Wolfe MM, Jensen RT. Zollinger-Ellison syndrome. Current concepts in diagnosis and management. N Engl J Med. 1987 Nov 5;317(19):1200-9. Review.

Moertel CG, Lavin PT, Hahn RG. Phase II trial of doxorubicin therapy for advanced islet cell carcinoma. Cancer Treat Rep. 1982 Jul;66(7):1567-9.

Broder LE, Carter SK. Pancreatic islet cell carcinoma. II. Results of therapy with streptozotocin in 52 patients. Ann Intern Med. 1973 Jul;79(1):108-18. No abstract available.

Study ID Numbers:	780133, 78-DK-0133
Study First Received:	November 3, 1999
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00001165
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Gastrinoma
Acid Secretion
Toxicity

Study placed in the following topic categories:

Gastrointestinal Diseases
Pancreatic Neoplasms
Pancrelipase
Stomach Diseases
Zollinger-Ellison Syndrome
Zollinger-Ellison syndrome
Neoplasm Metastasis
Peptic Ulcer
Endocrine Gland Neoplasms
Digestive System Neoplasms
Ulcer
Endocrine System Diseases
Adenoma, Islet Cell

Intestinal Diseases
Streptozocin
Doxorubicin
Digestive System Diseases
Gastrinoma
Paraneoplastic Syndromes
Fluorouracil
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Disease
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Paraneoplastic Endocrine Syndromes
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Syndrome
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009