A Phase I Study of Intraperitoneal Hyperthermic Docetaxel

NCT00474669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-09

No results posted yet for this study

Summary

The primary objective is to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma.

Conditions

  • Ovarian Carcinoma

Interventions

DRUG

docetaxel

Docetaxel will be administered in normal-saline delivered at an inflow temperature of 42 degreesC for 90 minutes by the technique described in Appendix D of the protocol

Sponsors & Collaborators

  • James Graham Brown Cancer Center

    collaborator OTHER
  • University of Louisville

    lead OTHER

Principal Investigators

  • C. William Helm, MD · James Graham Brown Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT00474669 on ClinicalTrials.gov