Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00112658|
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : March 8, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin||Phase 2 Phase 3|
- 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)
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||342 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||November 2004|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 30, 2010|
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Active Comparator: Gemcitabine||
Drug: gemcitabine hydrochloride
- Objective response rate (Phase II)
- Survival (Phase III)
- Progression-free survival (Phase III)
- Quality of life (Phase III)
- Overall response rate (Phase III)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112658
|Study Chair:||Thierry Conroy, MD||Centre Alexis Vautrin|