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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.
Full description
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
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84 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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