Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416767
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2006-12-27
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:
Federation Francophone de Cancerologie Digestive
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 duodenumpancreas 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 duodenumpancreas 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PFIZER-FFCD-0302 | None | None | None |
| FFCD-0302 | None | None | None |
| EU-20544 | None | None | None |