Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010088
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2001-02-02
Brief Title:
Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Study Of Gemcitabine Leukovorin And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas
Status:
UNKNOWN
Status Verified Date:
2007-04
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine leucovorin and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine leucovorin and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct
Detailed Description:
OBJECTIVES I Determine the response rate in terms of WHO objectives and clinical benefit in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated with gemcitabine leucovorin calcium and fluorouracil II Determine the tolerance of this regimen in this patient population III Determine the survival without disease progression in patients treated with this regimen IV Determine the overall survival in patients treated with this regimen
OUTLINE This is a multicenter study Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2 Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response may continue chemotherapy for up to 1 year Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks or may undergo surgical resection Fluorouracil-based chemotherapy with or without radiotherapy may then resume after surgery Patients are followed for survival
PROJECTED ACCRUAL A total of 14-39 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2 Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response may continue chemotherapy for up to 1 year Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks or may undergo surgical resection Fluorouracil-based chemotherapy with or without radiotherapy may then resume after surgery Patients are followed for survival
PROJECTED ACCRUAL A total of 14-39 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 |
|---|---|---|---|
| FRE-GERCOR-FOLFUGEM2-D99-3 | None | None | None |
| EU-20024 | None | None | None |