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

Primary Purpose

Islet Cell Adenoma, Neoplasm Metastasis, Zollinger Ellison Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin

About this trial

This is an interventional treatment trial for Islet Cell Adenoma focused on measuring Gastrinoma, Acid Secretion, Toxicity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00001165

First Posted

November 3, 1999

Last Updated

March 3, 2008

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00001165

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2003

Overall Recruitment Status

Completed

Study Start Date

September 1978 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Islet Cell Adenoma, Neoplasm Metastasis, Zollinger Ellison Syndrome

Keywords

Gastrinoma, Acid Secretion, Toxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

999 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

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

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

3309661

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. doi: 10.1056/NEJM198711053171907.

Results Reference

background

PubMed Identifier

6284361

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.

Results Reference

background

PubMed Identifier

4352784

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. doi: 10.7326/0003-4819-79-1-108. No abstract available.

Results Reference

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

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