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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001165 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Islet Cell Adenoma Neoplasm Metastasis Zollinger Ellison Syndrome |
Drug: combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 999 |
| Study Start Date: | September 1978 |
| Estimated Study Completion Date: | August 2003 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 780133, 78-DK-0133 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001165 History of Changes |
| Health Authority: | United States: Federal Government |
|
Gastrinoma Acid Secretion Toxicity |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Pancreatic Neoplasms Physiological Effects of Drugs Antibiotics, Antineoplastic Paraneoplastic Endocrine Syndromes Neoplastic Processes Stomach Diseases Neoplasms by Site Pathologic Processes Therapeutic Uses |
Zollinger-Ellison Syndrome Syndrome Neoplasm Metastasis Peptic Ulcer Endocrine Gland Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Disease Carcinoma, Islet Cell Endocrine System Diseases Adenoma, Islet Cell Streptozocin Intestinal Diseases Immunosuppressive Agents Pharmacologic Actions |
