A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

Brief summary public domain (ClinicalTrials.gov)

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery [30 days]. Number, percentage of participants (95% Confidence Interval). Liposomal Irinotecan With FOLFOX (n=29): 10.3 (2.2 to 27).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Subjects Who Completed All Intended Cycles of Treatment [4 months]. Number, percentage of participants. Liposomal Irinotecan With FOLFOX (n=45): 73.3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Subjects Who Achieved a Complete Surgical Resection (R0) [7 months]. Number, percentage of participants (95% Confidence Interval). Liposomal Irinotecan With FOLFOX (n=29): 89.7 (72 to 97).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Patients Achieving a Best Overall Response of Partial or Complete Response (Objective Response Rate) [5 months]. Number, percentage of participants (95% Confidence Interval). Liposomal Irinotecan With FOLFOX (n=38): 44.7 (29 to 62).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Difference Between Baseline and Maximal Nadir of Serum CA19-9 Level [9 months]. Mean, units/mL (Standard Deviation). Liposomal Irinotecan With FOLFOX (n=45): 756.9 (2932.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Subject Physical, Social, Emotional, and Functional Well-being During Treatment [Cycles 1, 5, and 8 and at pre-surgical evaluation and post-surgical follow-up visits]. Mean, score on a scale (Standard Deviation). Physical well-being (Cycle 1): Liposomal Irinotecan With FOLFOX (n=45): 5.1 (4.8). Social well-being (Cycle 1): Liposomal Irinotecan With FOLFOX (n=45): 24.7 (4). Emotional well-being (Cycle 1): Liposomal Irinotecan With FOLFOX (n=45): 8.7 (4.3). Functional well-being (Cycle 1): Liposomal Irinotecan With FOLFOX (n=45): 19.8 (5). Total score (Cycle 1): Liposomal Irinotecan With FOLFOX (n=45): 58.4 (6.6). Physical well-being (Cycle 5): Liposomal Irinotecan With FOLFOX (n=45): 8.4 (4.8). Social well-being (Cycle 5): Liposomal Irinotecan With FOLFOX (n=45): 24.2 (4.2). Emotional well-being (Cycle 5): Liposomal Irinotecan With FOLFOX (n=45): 7.4 (4.6). Functional well-being (Cycle 5): Liposomal Irinotecan With FOLFOX (n=45): 18.5 (5.9). Total score (Cycle 5): Liposomal Irinotecan With FOLFOX (n=45): 58.5 (9.9). Physical well-being (Cycle 8): Liposomal Irinotecan With FOLFOX (n=45): 8.1 (4.9). Social well-being (Cycle 8): Liposomal Irinotecan With FOLFOX (n=45): 24.5 (3.9). Emotional well-being (Cycle 8): Liposomal Irinotecan With FOLFOX (n=45): 8.3 (4.3). Functional well-being (Cycle 8): Liposomal Irinotecan With FOLFOX (n=45): 18.3 (5.2). Total score (Cycle 8): Liposomal Irinotecan With FOLFOX (n=45): 59.2 (8.3). Physical well-being (Pre-surgical evaluation): Liposomal Irinotecan With FOLFOX (n=45): 5.9 (4.4). Social well-being (Pre-surgical evaluation): Liposomal Irinotecan With FOLFOX (n=45): 24.5 (3.7). Emotional well-being (Pre-surgical evaluation): Liposomal Irinotecan With FOLFOX (n=45): 8.1 (4). Functional well-being (Pre-surgical evaluation): Liposomal Irinotecan With FOLFOX (n=45): 19.1 (5.7). Total score (Pre-surgical evaluation): Liposomal Irinotecan With FOLFOX (n=45): 57.6 (8.1). Physical well-being (Follow-up): Liposomal Irinotecan With FOLFOX (n=45): 8.5 (5.5). Social well-being (Follow-up): Liposomal Irinotecan With FOLFOX (n=45): 24.6 (3.8). Emotional well-being (Follow-up): Liposomal Irinotecan With FOLFOX (n=45): 7.8 (4). Functional well-being (Follow-up): Liposomal Irinotecan With FOLFOX (n=45): 15.4 (5.9). Total score (Follow-up): Liposomal Irinotecan With FOLFOX (n=45): 56.4 (8.1).