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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Ketoconazole
Sponsored by
Kansas City Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Neoadjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kansas City VAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 24, 2008
Last Updated
March 25, 2009
Sponsor
Kansas City Veteran Affairs Medical Center
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00870714
Brief Title
Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study
Acronym
IST 16167
Official Title
Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kansas City Veteran Affairs Medical Center
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Neoadjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 55mg/m2 to be given IV as a one-hour infusion to be repeated every 21 days for four treatment cycles.
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kansas City VAMC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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