A Phase II Study to Evaluate the Efficacy of Nanoliposomal Irinotecan in Combination with Oxaliplatin, Leucovorin, and 5-Fuorouracil for Patients with Locally Advanced Pancreatic Carcinoma: Big Ten Cancer Research Consortium BTCRC-GI15-067
Objective
Primary Objective: Determine the disease control rate (DCR) of liposomal irinotecan (nal-IRI) in combination with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) for treatment of locally advanced pancreatic carcinoma.
Secondary Objectives: 1. Assess the objective response rate (ORR) at 8 weeks, 16 weeks, and 24 weeks following starting FOLFOX-nal-IRI. 2. Assess the stable disease rate (SDR) at 8 weeks, 16 weeks, and 24 weeks following starting FOLFOX-nal-IRI. 3. Examine the rate of tumor resection. 4. Analyze the response of serum CA 19-9 every 2 cycles (every 4 weeks) following starting FOLFOX-nal-IRI. 5. Determine progression-free survival (PFS). 6. Determine overall survival (OS). 7. Evaluate safety and tolerability of FOLFOX-nal-IRI. 8. Assess the quality of life every 4 cycles (every 8 weeks) following starting FOLFOX-nal-IRI.
Exploratory Objectives: ? Determine the UGT1A1 genotype and correlate with toxicity of treatment. ? Determine FOLFOX-nal-IRI induced DNA damage/repair and apoptosis in biopsied and surgically resected tumor tissues. ? Determine DNA damage in blood-based biopsies prior to treatment and following every 4 cycles (8 weeks) of treatment. ? Determine the tumor molecular profile prior to initiation of chemotherapy and correlate with treatment responses. ? Determine the metabolic profiles of plasma prior to treatment and following every 4 cycles (8 weeks) of treatment.
