NCT00001165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 1978

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1978

Completed
21.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Islet Cell AdenomaNeoplasm MetastasisZollinger Ellison Syndrome

Keywords

GastrinomaAcid SecretionToxicity

Interventions

combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Wolfe MM, Jensen RT. Zollinger-Ellison syndrome. Current concepts in diagnosis and management. N Engl J Med. 1987 Nov 5;317(19):1200-9. doi: 10.1056/NEJM198711053171907.

    PMID: 3309661BACKGROUND

  • 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.

    PMID: 6284361BACKGROUND

  • 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. doi: 10.7326/0003-4819-79-1-108. No abstract available.

    PMID: 4352784BACKGROUND

MeSH Terms

Conditions

Adenoma, Islet CellNeoplasm MetastasisZollinger-Ellison SyndromeGastrinoma

Interventions

StreptozocinFluorouracilDoxorubicin

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsParaneoplastic Endocrine SyndromesParaneoplastic SyndromesGastrointestinal NeoplasmsGastrointestinal DiseasesPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach DiseasesCarcinoma, Islet CellAdenocarcinomaCarcinoma

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsAminoglycosidesGlycosidesCarbohydratesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

September 1, 1978

Study Completion

August 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-08

Locations

US(1)