Status:
UNKNOWN
Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study
Lead Sponsor:
Kansas City Veteran Affairs Medical Center
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 cy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00870714
Start Date
September 1 2004
Last Update
March 27 2009
Active Locations (1)
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1
Kansas City VAMC
Kansas City, Missouri, United States, 64128