Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-26 @ 1:50 PM
Study NCT ID:
NCT00416767
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2006-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors of the Duodenum or Pancreas That Cannot Be Removed By Surgery
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Study Overview
Official Title:
Study of First-Line Therapy Comprising Leucovorin Calcium, Fluorouracil, and Irinotecan (FOLFIRI) in Patients With Progressive Locally Advanced or Metastatic Duodenal-Pancreatic Endocrine Tumors
Status:
COMPLETED
Status Verified Date:
2016-05
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:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works as first-line therapy in treating patients with locally advanced or metastatic neuroendocrine tumors of the duodenum or pancreas that cannot be removed by surgery.
PURPOSE: This phase II trial is studying how well combination chemotherapy works as first-line therapy in treating patients with locally advanced or metastatic neuroendocrine tumors of the duodenum or pancreas that cannot be removed by surgery.
Detailed Description:
OBJECTIVES:
Primary
* 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 chemotherapy.
Secondary
* 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 regimen.
* 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.
Primary
* 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 chemotherapy.
Secondary
* 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 regimen.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: