Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-01 @ 2:55 AM
Study NCT ID:
NCT00112658
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2005-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
UNICANCER
Organization:
Study Overview
Official Title:
Randomized Phase II/III 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 II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.
PURPOSE: This randomized phase II/III 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:
True
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?: