Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study (IST 16167)

March 25, 2009 updated by: Kansas City Veteran Affairs Medical Center
Eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection. A cycle of therapy is defined as 21 days (three weeks). Pharmacokinetic analysis will be performed with the first and second cycle of therapy. All patients will be evaluated for toxicity, tumor response, and recurrence.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VAMC

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients must have histologically proven adenocarcinoma of the prostate.

  • Patients must meet at least one of the following high risk criteria:

    • PSA > 20
    • Gleason score 8 or greater
    • Presence of pathological Gleason grade 4 or higher as the majority sum on biopsy core
    • Greater than 50% of cores at time of biopsy positive for cancer
    • Clinical Stage T3 Disease
    • Patients must have PS of 0-1(ECOG) and medically deemed a surgical candidate for radical prostatectomy.
    • Age > or = to 18.
    • Patients with a pre-existing peripheral neuropathy of equal to or greater than grade two are ineligible.
    • Serum Creatinine must be < or equal to 2.0mg/dl.
    • Patients must currently not receiving any drug which is metabolized by cytochrome P450-3A4 including the statins, cyclosporin, terfenadine and erythromycin.
    • Prior to receiving any dose of docetaxel, patients should have absolute neutrophil counts > 1,500, hemoglobin > 8.0 g/dl and platelet counts > 100,000/mm3.
    • Patients with bilirubin elevated above institutional upper limit of normal (ULN)must be excluded. Transaminases (SGOT and/or SGPT) may be up to 5.0 x institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 5 x ULN if transaminases are < ULN. However, patients who have both transaminase elevation > 1.5 x ULN and alkaline phosphatase > 2.5 x ULN are not eligible for this study (due to decrease clearance of docetaxel and increased risk of toxicity).
    • Patients receiving concurrent warfarin are eligible but require monitoring of protime on a weekly basis.
    • Patients with clinical stage T4 disease are not eligible.
    • Patients must not had have received prior treatment with surgery, radiation or hormone deprivation.
    • Patients with other primary malignancies previously treated with chemotherapeutic agents are not eligible.
    • Patients must not have had a history of peptic ulcer disease requiring treatment with surgery or endoscleral.
    • Patients requiring corticosteroids for other systemic diseases are not eligible.
    • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are not eligible.
    • All patients must sign informed consent.
    • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection
Drug: Docetaxel
Docetaxel 55mg/m2 to be given IV as a one-hour infusion to be repeated every 21 days for four treatment cycles.
Drug: Ketoconazole
Ketoconazole 400mg P.O. BID daily to start on day 2 following the first docetaxel treatment. In patients who experience no grade 2 or higher toxicity, the ketoconazole dose will be increased to 400mg TID on day 2 following cycle #2 of docetaxel. This will be continued daily until completion of study treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the pathologic response rate of neoadjuvant therapy with the combination of docetaxel and ketoconazole given to patients who are at a high risk of recurrence of prostate cancer.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess in preliminary fashion whether of this treatment will decrease the incidence of biochemical recurrence and provide a survival benefit as compared to patients with local treatment only or other adjuvant therapies.
Time Frame: One Year
One Year

Collaborators and Investigators

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

Sponsor

Kansas City Veteran Affairs Medical Center

Collaborators

Sanofi

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

September 1, 2004

Primary Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

March 27, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sanofi-Aventis IST 16167

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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