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

NCT01959139 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-02-09

Study results available
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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.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

PEGPH20

3 ug/kg on Day 1, IV over 15 minutes

DRUG

Oxaliplatin

85 mg/m\^2, on Day 2, IV over 2 hours

DRUG

Leucovorin

400 mg/m\^2, on Day 2, IV over 2 hours

DRUG

Irinotecan

180 mg/m\^2, on Day 2, IV over 1.5 hours

DRUG

5-fluorouracil

2,400 mg/m\^2, Days 2-4, IV over 46 hours

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Halozyme Therapeutics

    collaborator INDUSTRY

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Ramesh K Ramanathan, M.D. · Virginia G. Piper Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-23
Primary Completion
2019-04-30
Completion
2023-11-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01959139 on ClinicalTrials.gov