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Streptozotocin, 5-Fluorouracil, and Doxorubicin in Zollinger-Ellison Syndrome and Metastatic Non-Beta-Islet Cell Neoplasm
NCT00001165Phase 2
Key facts
- Status
- Completed
- Start
- Sep 1978
- Countries
- 1
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases
- Modality
- DNA Intercalators/Alkylators
- Conditions
- Zollinger–Ellison syndrome (ZES)Pancreatic neuroendocrine tumor (PanNET)
01
Overview
Phase 2, open-label, single-arm trial of streptozocin, fluorouracil and doxorubicin in Zollinger–Ellison syndrome (ZES) and Pancreatic neuroendocrine tumor (PanNET), sponsored by National Institute of Diabetes and Digestive and Kidney Diseases. Primary endpoint: Objective Response Rate. Started Sep 1978; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Combined Chemotherapy
streptozotocin, 5-fluorouracil, and doxorubicin
03
Who it enrols
Patients with Zollinger-Ellison syndrome and histologically proven gastrinoma with evidence of metastatic or locally invasive disease that has progressed in the last 6 months. Must have adequate renal and hematologic function and no congestive heart failure.
04
Endpoints
Primary
Objective Response Rate
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