Study of First-Line Therapy Comprising Leucovorin Calcium, Fluorouracil, and Irinotecan (FOLFIRI) in Patients With Progressive Locally Advanced or Metastatic Duodenal-Pancreatic Endocrine Tumors
- Determine the 6-month progression-free survival rate in patients with unresectable
locally advanced or metastatic neuroendocrine tumors of the duodenum/pancreas treated
with fluorouracil, leucovorin calcium, and irinotecan hydrochloride as first-line
- Determine tumor and biologic response at 6, 12, 18, and 24 months in patients treated
with this regimen.
- Determine the duration of response of the primary tumor in patients treated with this
- Determine the tolerability of this regimen in these patients.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over
2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2. Courses repeat every 14
days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 1 year and then
every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
CHU - Robert Debre
United States: Federal Government