A Phase I Study of Intraperitoneal Hyperthermic Docetaxel (IP)

January 5, 2018 updated by: University of Louisville

A Phase I Study of Intraperitoneal Hyperthermic Docetaxel at the Time of Second Look Surgery Following Front-Line Normothermic Intraperitoneal and Intravenous Cisplatin/Paclitaxel for Patients With Stage II and III Ovarian Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase I study of intraperitoneal hyperthermic docetaxel given at the time of second look surgery following front-line normothermic intraperitoneal and intravenous cisplatin/paclitaxel for patients with stage II and III ovarian carcinoma. The primary objectives are to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at this time and assess the toxicity and morbidity associated with this treatment. Eligible patients will have had a complete clinical response to front-line therapy.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients must have had a complete clinical response (negative clinical examination, CA125 and CT scan of chest, abdomen and pelvis) to front-line therapy for stage II/III ovarian, primary peritoneal or Fallopian tube carcinoma. This will have included initial surgery followed by combined IV/IP chemotherapy with cisplatin and paclitaxel. Patients must have had a minimum of three courses of IP therapy with both paclitaxel and cisplatin
  • Second surgery to be performed no more than 3 months from last course of initial chemotherapy
  • Age greater than 18 years and negative pregnancy if has child-bearing potential
  • GOG performance status less than 2
  • Medically fit for surgery
  • Patients must have normal organ and marrow function as defined in the protocol hepatic function Total Bilirubin ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values AST or ALT) should be used.
  • Ability to understand and the willingness to sign a written informed consent document.
  • The effects of docetaxel on the developing human fetus are unknown. For this reason and because taxanes are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

  • Patients who have completed front-line therapy for ovarian cancer more than 3 months prior to HIPEC.
  • Patients receiving any other investigational agents.
  • Patients with stage IV disease including previous parenchymal liver disease, brain metastasis or cytologically-confirmed chest metastasis
  • Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition used in this study in addition to Taxotere.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • More than grade 2 peripheral neuropathy from prior chemotherapy
  • Pregnant, breast-feeding or known to be HIV positive
  • Prior malignancy other than non-melanomatous skin cancer more than 5 years ago
  • No prior chemotherapy other than for front-line ovarian cancer or radiation for any reason.
  • Stomatitis of any grade
  • Uncontrolled intercurrent illness or other conditions that would limit compliance with study requirements should be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel
Intraperitoneal Docetaxel administered with heat
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the MTD of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma following surgery and normothermic intraperitoneal and intravenous cisplatin and paclitaxel.
Time Frame: 6 months-5 years
6 months-5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the quality of life of patients treated with intraperitoneal hyperthermic chemotherapy in this setting
Time Frame: 6 months-5 years
6 months-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

Investigators

  • Principal Investigator: C. William Helm, MD, James Graham Brown Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1 - R. Bruno, D. Hille, L. Thomas, A. Riva and L.B. Sheiner. Population Pharmacokinetics / Pharmacodynamics (PK/PD) of Docetaxel (Taxotere) in Phase II studies. Proc. ASCO, 14, 457, 1995. 2 - S. L. Beal, A.J. Boeckman and L.B. Sheiner. NONMEM version 4. User's Guide Part I to VI. University of California at San Francisco, San Francisco, 1988 - 1992.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 15, 2007

First Submitted That Met QC Criteria

May 16, 2007

First Posted (Estimate)

May 17, 2007

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCC-GYN-07-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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