Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both arms will continue treatment until disease progression or unacceptable toxicity.

Detailed description public domain (ClinicalTrials.gov)

OUTLINE: This is a multi-center study. EXPERIMENTAL ARM A: * Oxaliplatin 85 mg/m\^2 over 2-4 hours * Irinotecan 165 mg/m\^2 over 90 minutes * 5-FU 2,400 mg/m\^2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia. * Arm A will receive ramucirumab (RAM) administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks. CONTROL ARM B : * Oxaliplatin 85 mg/m2 over 2-4 hours * Irinotecan 165 mg/m2 over 90 minutes * 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia. * Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were RAM. In order to demonstrate adequate organ function, all screening labs must be obtained within 7 days prior to registration: Hematological: * Hemoglobin ≥ 9 g/dL * Absolute Neutrophil Count (ANC) ≥ 1,500/mm\^3 * Platelet Count (PLT) ≥ 100,000/mm\^3 Renal: * Creatinine ≤ 1.5 mg/dL or Creatinine clearance\^1 ≥ 40 mL/min * Albumin ≥ 2.5 g/dL Hepatic: * Bilirubin ≤ 1.5 mg/dL * Aspartate aminotransferase (AST) ≤ 3 × ULN or \< 5 xULN in the setting of liver metastases * Alanine aminotransferase (ALT) ≤ 3 × ULN or \< 5 xULN in the setting of liver metastases Coagulation: * International Normalized Ratio (INR) (Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy) ≤1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) \< 1.5 x ULN

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

Progression Free Survival (PFS) at 9 Month [9 months]. Number, Percentage of participants (95% Confidence Interval). Arm A: Experimental Arm (n=42): 25.1 (11.6 to 41.3); Arm B: Placebo Arm (n=40): 35 (19.8 to 50.6).

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

Overall Survival (OS) [Up to a maximum of 53 months]. Median, Months (95% Confidence Interval). Arm A: Experimental Arm (n=42): 10.3 (6 to 11.8); Arm B: Placebo Arm (n=40): 9.7 (6.4 to 15.9).

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

Response Rate (RR) [Up to 44 months]. Number, Percentage of participants. Arm A: Experimental Arm (n=34): 17.7; Arm B: Placebo Arm (n=31): 22.6.

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

Number of Participants With Adverse Events [From date of first dose until 30 days after the last treatment, assessed up to 44 months]. Count Of Participants, Participants. Arm A: Experimental Arm (n=42): 42; Arm B: Placebo Arm (n=40): 40.