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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
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

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

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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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
No
Eligibility 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.
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
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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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