S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer

Conditions

• Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• PEGPH20 — DRUG
  3 ug/kg on Day 1, IV over 15 minutes
• Oxaliplatin — DRUG
  85 mg/m\^2, on Day 2, IV over 2 hours
• Leucovorin — DRUG
  400 mg/m\^2, on Day 2, IV over 2 hours
• Irinotecan — DRUG
  180 mg/m\^2, on Day 2, IV over 1.5 hours
• 5-fluorouracil — DRUG
  2,400 mg/m\^2, Days 2-4, IV over 46 hours

Study Details

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.

Key Dates

Start date

Jan 23, 2014

Status verified

Feb 2024

Primary completion

Apr 30, 2019

Completion

Nov 9, 2023

Study Design

Enrollment

126 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Phase II: mFOLFIRINOX
  Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Phase II: mFOLFIRINOX + PEGPH20
  Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Phase I
  PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes; Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours; Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours; Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours; 5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours

Primary Outcome Measure

Phase I: Maximum Tolerated Dose (MTD) of PEGPH20 in Combination With mFOLFIRINOX [ Time Frame: 2 cycles of 14 days ]

Locations (154)

Find similar trials in Anchorage, AK

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