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Protocol Summary


Protocol No.
PSCI-18-059
Prinicipal Investigator
Yee, Nelson Shu-sang
Phase
Phase II
Age Group
Adult
Scope
Local
Secondary Protocol No.
18-059; BTCRC-GI15-067
Title
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.
Applicable Disease Sites
Pancreas
Status
Open
Participating Institutions
Hershey Medical Center