Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

Brief summary public domain (ClinicalTrials.gov)

This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).

Detailed description public domain (ClinicalTrials.gov)

This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC). Each subject will be screened for eligibility by evaluation including medical history, physical examination, performance status, blood tests, computed tomographic (CT) scans, and electrocardiogram. Within 28 days of screening, the consented subjects will have a central venous access device placed and then start treatment. For every 2-week cycle of FOLFOX-nal-IRI, each subject will receive nal-IRI (irinotecan free base 50 mg/m2 intravenously over 90 minutes), oxaliplatin (60 mg/m2 intravenously over 2 hours), leucovorin (400 mg/m2 intravenously over 2 hours), and 5-fluorouracil 2,400 mg/m2 intravenously over 46 hours). Tumor response/surgical assessment will be evaluated after every 4 cycles of treatment with CT scans using RECIST 1.1 criteria. If the tumor becomes surgically resectable and the subject is a surgical candidate as determined by a multidisciplinary team, the subject will undergo surgery (at which point he/she would enter survival follow-up). If the tumor remains unresectable and there is no tumor progression, each subject will be treated up to a total of 12 cycles of FOLFOX-nal-IRI. Following treatment with 12 cycles of FOLFOX-nal-IRI, if tumor remains unresectable, the subjects may receive further treatment (chemotherapy using the same regimen or of the treating physician's choice, or chemoradiation therapy) or observation as determined by the physician. During the course of treatment, if the subjects develop unacceptable toxicity and/or disease progression, the treatment will be discontinued, and the subjects will be further managed at the discretion of the treating oncologists.

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

Disease Control Rate (DCR) [Up to 22 months]. Number, Percentage of participants. FOLFOX + Irinotecan (n=26): 73.

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

Objective Response Rate (ORR) at 8 Weeks [8 weeks]. Number, Percentage of participants. FOLFOX + Irinotecan (n=25): 16.

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

Objective Response Rate (ORR) at 16 Weeks [16 weeks]. Number, Percentage of participants. FOLFOX + Irinotecan (n=19): 21.

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

Objective Response Rate (ORR) at 24 Weeks [24 weeks]. Number, Percentage of participants. FOLFOX + Irinotecan (n=16): 25.

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

Stable Disease Rate (SDR) at 8 Weeks [8 Weeks]. Number, Percentage of participants. FOLFOX + Irinotecan (n=25): 84.

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

Stable Disease Rate (SDR) at 16 Weeks [16 Weeks]. Number, Percentage of participants. FOLFOX + Irinotecan (n=19): 89.

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

Stable Disease Rate (SDR) at 24 Weeks [24 Weeks]. Number, Percentage of participants. FOLFOX + Irinotecan (n=15): 80.

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

Proportion of Subjects Able to Undergo Surgical Resection [12 months]. Number, Proportion of participants. FOLFOX + Irinotecan (n=21): 0.095.

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

Response of Serum CA19-9 Levels [Up to 7 months]. Mean, Percentage Change from Baseline (Standard Deviation). Best response: PR: FOLFOX + Irinotecan (n=25): -69 (37.41). Best response: SD: FOLFOX + Irinotecan (n=25): -41 (40.87). Best response: PD: FOLFOX + Irinotecan (n=25): 31 (8.04).

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

Progression-Free Survival (PFS) [Up to 22 months]. Median, Months (95% Confidence Interval). FOLFOX + Irinotecan (n=26): 8.1 (5.19 to 12.1).

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

Overall Survival (OS) [Up to 31 months]. Median, Months (95% Confidence Interval). FOLFOX + Irinotecan (n=26): 18 (11.3 to 22.5).

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

Number of Participants With Adverse Events [Up to 7 months]. Count Of Participants, Participants. FOLFOX + Irinotecan (n=28): 28.

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

Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30) [Treatment Cycle 1 (14 days), Treatment Cycle 5 (70 days), Treatment Cycle 9 (126 days), Follow-Up (7 Months)]. Mean, score on a scale (Standard Deviation). Treatment Cycle 1: FOLFOX + Irinotecan (n=14): 66.7 (26.4). Treatment Cycle 5: FOLFOX + Irinotecan (n=14): 69.4 (25.5). Treatment Cycle 9: FOLFOX + Irinotecan (n=14): 68.5 (16.7). Follow-Up: FOLFOX + Irinotecan (n=14): 76.4 (17.0).