Status:
TERMINATED
A Study of Ixabepilone Before Surgery for High-Risk Localized Prostate Cancer
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Prostatic Diseases
Genital Neoplasms, Male
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery. Prostate c...
Eligibility Criteria
Inclusion
- Histologically-confirmed localized prostate cancer
- Predicted probability of recurrence \>/= 30% as defined by the updated Kattan nomogram
- Pathologic material available for gene expression analysis including cancer present in 2 or more cores and availability of unstained slides or formalin-fixed paraffin embedded tissue blocks.
- No prior prostate cancer therapy (including hormonal, chemotherapy, radiation or surgery)
- Subjects must be considered as candidates for radical prostatectomy
- EGOG status
- Men of child-bearing potential are required to use an effective means of contraception
- Required Initial Laboratory Values:
- ANC \>/= 1500/uL
- Platelet Count \>/= 100000/uL
- Creatinine Bilirubin AST \< 2.5 X ULN
- ALT \< 2.5 X ULN
- Hemoglobin \>/= 9.0 g/dL
Exclusion
- A history of significant ventricular arrhythmias
- Neuropathy (\> grade 1)
- Recent (within 6 months) myocardial infarction, congestive heart failure, transient ischemic attack or stroke
- Active angina, including active stable and unstable angina
- Acute deep venous thrombosis and/or pulmonary embolism in the past 6 months
- Any prior hormonal therapy including the use of PC Spes or estrogen containing nutriceuticals
- Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma.
- Patients with malignancy diagnosed more than 5 years ago and are disease free for at least 5 years are not excluded.
- Recent (within 4 weeks) surgery or incomplete healing from surgery
- Known history of hypersensitivity reaction to a drug formulated in Cremophor EL
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment
- Active infection requiring antibiotic therapy, or serious intercurrent illness.
- Any other major illness that in the investigators judgment will substantially increase the risk associated with the subject's participation in this study.
- Unwillingness or inability to comply with procedures required in this protocol.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00672009
Start Date
April 1 2008
End Date
August 1 2012
Last Update
October 24 2018
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048