NCT02345460

Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Adenocarcinoma
• Poorly Differentiated Malignant Neoplasm
• Resectable Pancreatic Cancer
• Stage IA Pancreatic Cancer
• Stage IB Pancreatic Cancer
• Stage IIA Pancreatic Cancer
• Stage IIB Pancreatic Cancer
• Stage III Pancreatic Cancer
• Undifferentiated Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	Irinotecan Hydrochloride	Given IV
DRUG	Oxaliplatin	Given IV
DRUG	Leucovorin Calcium	Given IV
DRUG	Fluorouracil	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2015-01-26
• Last updated: 2018-07-13
• Results posted: 2018-07-13

Locations

1 site across 1 country: United States