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Intraperitoneal Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Cancer of the Peritoneal Cavity

NCT00825201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-01-19

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation directly into the abdomen may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced cancer of the peritoneal cavity.

Conditions

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

paclitaxel albumin-stabilized nanoparticle formulation

Given IP

OTHER

liquid chromatography

Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.

OTHER

mass spectrometry

Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.

OTHER

pharmacological study

Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Mihaela Cristea, MD · City of Hope Comprehensive Cancer Center

  • Mihaela Cristea, MD · City of Hope Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2018-01-16
Completion
2018-01-16

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00825201 on ClinicalTrials.gov