Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001165
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 78-DK-0133 | None | None | None |