Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Islet Cell Adenoma Neoplasm Metastasis Zollinger Ellison Syndrome |
| Intervention | Drug: combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin |
| Phase | Phase 2 |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Responsible Party | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier | NCT00001165 |
| First Received | November 3, 1999 |
| Last Updated | March 3, 2008 |
| Last verified | August 2003 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 3, 1999 |
|---|---|
| Last Updated Date | March 3, 2008 |
| Start Date | September 1978 |
| Estimated Primary Completion Date | August 2003 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas |
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| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 999 |
| Estimated Completion Date | August 2003 |
| Estimated Primary Completion Date | Not Provided |
| 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. |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00001165 |
|---|---|
| Other Study ID Numbers | 780133 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Study Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | August 2003 |
Locations[ + expand ][ + ]
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Bethesda, Maryland, United States, 20892 |
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