Expired Study
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Bethesda, Maryland 20892


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.


Study 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.


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.


Study is Available At:


Original ID:

780133


NCT ID:

NCT00001165


Secondary ID:

78-DK-0133


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

999


Enrollment Type:


Study Dates

Start Date:September 1978
Completion Date:August 2003
Verification Date:August 2003
Last Changed Date:March 3, 2008
First Received Date:November 3, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:combined chemotherapy with streptozotocin, 5-fluor

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:3309661
Reference Type:Reference
Citation: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.
PMID:6284361
Reference Type:Reference
Citation: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.
PMID:4352784

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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