At a glance
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S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating PEGPH20, Oxaliplatin, and 3 other interventions for Metastatic Pancreatic Adenocarcinoma. Completed, enrolled 126 participants across 154 sites.
Detailed Summary
This partially randomized phase I/II trial studies the side effects and best dose of pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination chemotherapy and to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed pancreatic cancer that has spread to other places in the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without pegylated recombinant human hyaluronidase in treating pancreatic cancer.
Study Details
Timeline
Interventions
3 ug/kg on Day 1, IV over 15 minutes
85 mg/m\^2, on Day 2, IV over 2 hours
400 mg/m\^2, on Day 2, IV over 2 hours
180 mg/m\^2, on Day 2, IV over 1.5 hours
2,400 mg/m\^2, Days 2-4, IV over 46 hours