Pancreatic Adenocarcinoma Clinical Trial
Official title:
Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study
This phase II trial studies how well combination chemotherapy works in treating patients with pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To determine feasibility of preoperative FOLFIRINOX for resectable pancreatic
adenocarcinoma.
SECONDARY OBJECTIVES:
I. To determine safety and toxicity of preoperative FOLFIRINOX. II. To determine response
rate. III. To determine proportion achieving major pathologic response - per College of
American Pathologists (CAP) criteria.
IV. To determine proportion achieving R0 resection. V. To determine perioperative (30-day)
mortality. VI. To determine the role of cancer antigen (CA)19.9 as potential prognostic
and/or predictive biomarker.
VII. To determine progression-free survival. VIII. To determine overall survival.
OUTLINE:
Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride intravenously (IV)
over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and
fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment
repeats every 14 days for 6 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months.
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