NCT02581215

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

Phase II Randomized, Double-Blind Study of mFOLFIRINOX Plus Ramucirumab Versus mFOLFIRINOX Plus Placebo in Advanced Pancreatic Cancer Patients: Hoosier Cancer Research Network GI14-198

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Walid Shaib, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	mFOLFIRINOX	mFOLFIRINOX: * 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.
DRUG	Ramucirumab	Ramucirumab 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.
OTHER	Placebo	Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.

Timeline

• Start date: 2016-09-11
• Primary completion: 2021-08-05
• Completion: 2022-01-27
• First posted: 2015-10-20
• Last updated: 2025-01-01
• Results posted: 2025-01-01

Locations

8 sites across 1 country: United States