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

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

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.

Trial Locations (3)

66160

University of Kansas Medical Center, Kansas City

67208

Cancer Center of Kansas, Wichita

73104

Peggy and Charles Stephenson Oklahoma Cancer Center, Oklahoma City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University of Kansas Medical Center

OTHER

collaborator

Beckloff Associates, Inc.

INDUSTRY

lead

CritiTech, Inc.

INDUSTRY