Know Cancer

or
forgot password

Evaluation of Chemotherapy With Streptozotocin Combined With 5-Fluorouracil and Adriamycin in Patients With Zollinger-Ellison Syndrome and Metastatic Non-Beta-Islet Cell Neoplasm


Phase 2
N/A
N/A
Not Enrolling
Both
Islet Cell Adenoma, Neoplasm Metastasis, Zollinger Ellison Syndrome

Thank you

Trial Information

Evaluation of Chemotherapy With Streptozotocin Combined With 5-Fluorouracil and Adriamycin in Patients With Zollinger-Ellison Syndrome and Metastatic Non-Beta-Islet Cell Neoplasm


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

780133

NCT ID:

NCT00001165

Start Date:

September 1978

Completion Date:

August 2003

Related Keywords:

  • Islet Cell Adenoma
  • Neoplasm Metastasis
  • Zollinger Ellison Syndrome
  • Gastrinoma
  • Acid Secretion
  • Toxicity
  • Adenoma
  • Neoplasms
  • Adenoma, Islet Cell
  • Neoplasm Metastasis
  • Pancreatic Neoplasms
  • Zollinger-Ellison Syndrome
  • Gastrinoma

Name

Location

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Bethesda, Maryland  20892