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Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers

NCT00666991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-02-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally confined to the peritoneal cavity.

Conditions

  • Peritoneal Neoplasms

Interventions

DRUG

nanoparticulate paclitaxel

This is a Phase 1, dose-escalation study with 6 cohorts of 1 - 6 patients. Patients receive Nanotax via intraperitoneal infusion once every 28 days continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced. Dosing cohorts are as follows: 50 mg/m2, 82.5 mg/m2, 125 mg/m2, 175 mg/m2, 225 mg/m2, and 275 mg/m2.

Sponsors & Collaborators

  • University of Kansas Medical Center

    collaborator OTHER

  • Beckloff Associates, Inc.

    collaborator INDUSTRY

  • CritiTech, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Johnson, M.D. · University of Kansas Medical Center

  • Julia Chapman, M.D. · University of Kansas Medical Center

  • Thomas K Schulz, M.D. · Cancer Center of Kansas

  • Kathleen Moore, MD · Peggy and Charles Stephenson Oklahoma Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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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 NCT00666991 on ClinicalTrials.gov