Neoplasm Metastasis Clinical Trial
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
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.
Status | Completed |
Enrollment | 999 |
Est. completion date | August 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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. — View 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. — View 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. — View Citation
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