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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Kansas City Veteran Affairs Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00870714
First received: July 24, 2008
Last updated: March 25, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: Docetaxel
Drug: Ketoconazole

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Kansas City Veteran Affairs Medical Center:

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. [ Time Frame: One year ] [ Designated as safety issue: No ]

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. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2004
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870714

Locations
United States, Missouri
Kansas City VAMC
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
Kansas City Veteran Affairs Medical Center
Sanofi
  More Information

No publications provided

Responsible Party: Peter VanVeldhuizen, M.D./Principal Investigator, Kansas City VAMC
ClinicalTrials.gov Identifier: NCT00870714     History of Changes
Other Study ID Numbers: Sanofi-Aventis IST 16167
Study First Received: July 24, 2008
Last Updated: March 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Kansas City Veteran Affairs Medical Center:
Prostate Cancer
Neoadjuvant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Ketoconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014