Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112658
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2005-06-02
Brief Title:
Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Randomized Phase IIIII Trial Comparing Folririnox Association Oxaliplatin Irinotecan LV5FU2 Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Status:
COMPLETED
Status Verified Date:
2021-03
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 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 It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer
PURPOSE This randomized phase IIIII trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer
PURPOSE This randomized phase IIIII trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin irinotecan leucovorin calcium and fluorouracil vs gemcitabine as first-line chemotherapy Phase II
Compare the survival of patients treated with these regimens Phase III
Secondary
Compare the toxicity of these regimens in these patients
Compare progression-free survival of patients treated with these regimens Phase III
Compare the overall response rate in patients treated with these regimens Phase III
Compare quality of life of patients treated with these regimens Phase III
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oxaliplatin IV over 2 hours irinotecan IV over 1½ hours leucovorin calcium IV over 2 hours and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Courses repeat every 14 days
Arm II Patients receive gemcitabine IV on days 1 8 15 22 29 36 and 43 Beginning on day 57 patients receive gemcitabine IV once weekly for 3 weeks days 57 64 and 71 Courses repeat every 28 days
PROJECTED ACCRUAL A total of 348 patients 88 for phase II and 260 for phase III will be accrued for this study
Primary
Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin irinotecan leucovorin calcium and fluorouracil vs gemcitabine as first-line chemotherapy Phase II
Compare the survival of patients treated with these regimens Phase III
Secondary
Compare the toxicity of these regimens in these patients
Compare progression-free survival of patients treated with these regimens Phase III
Compare the overall response rate in patients treated with these regimens Phase III
Compare quality of life of patients treated with these regimens Phase III
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oxaliplatin IV over 2 hours irinotecan IV over 1½ hours leucovorin calcium IV over 2 hours and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Courses repeat every 14 days
Arm II Patients receive gemcitabine IV on days 1 8 15 22 29 36 and 43 Beginning on day 57 patients receive gemcitabine IV once weekly for 3 weeks days 57 64 and 71 Courses repeat every 28 days
PROJECTED ACCRUAL A total of 348 patients 88 for phase II and 260 for phase III will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| EU-20512 | None | None | None |
| FRE-FNCLCC-ACCORD-110402 | None | None | None |