Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075738
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2004-01-09
Brief Title:
Fluorouracil Irinotecan Leucovorin and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 irinotecan leucovorin and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one chemotherapy drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer
PURPOSE This phase II trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil irinotecan leucovorin calcium and cisplatin as first-line therapy
Secondary
Determine the clinical benefit in patients treated with this regimen
Determine the tolerability of this regimen in these patients
Determine local relapse-free survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2 Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study within 1 year
Primary
Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil irinotecan leucovorin calcium and cisplatin as first-line therapy
Secondary
Determine the clinical benefit in patients treated with this regimen
Determine the tolerability of this regimen in these patients
Determine local relapse-free survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2 Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study within 1 year
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20328 | None | None | None |
| FRE-GERCOR-D00-2 | None | None | None |