Expired Study
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Providence, Rhode Island 02906


Purpose:

Ixabepilone will be given IV weekly for 12 weeks prior to prostatectomy for patients with localized, high risk prostate cancer. The objective of this study is to determine if ixabepilone can shrink prostate cancer prior to prostatectomy.


Study summary:

Ixabepilone will be given IV weekly for 12 weeks, in an intensive 20 mg/m2/week schedule, prior to prostatectomy for patients with localized, high risk prostate cancer. The objective of this study is to determine the PSA response and pathologic complete response of weekly ixabepilone.


Criteria:

Inclusion Criteria: - Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine or transitional cell carcinomas are not eligible. - All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration. - Clinically Localized Disease: Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by: - Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes > 1 cm: or endorectal MRI(If one or more lymph nodes(s) measures > 1 cm, a negative biopsy is required.) - Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if necessary).(Positive PET and Prostascint scans are not considered proof of metastatic disease.) - Patients must have high risk disease defined as either: - Gleason Score 8-10 - PSA > 15 ng/ml - Stage T3a - Stage T2c and Gleason score of 7 - Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a single lobe. - No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy. - Patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by an urologist. - ECOG PS 0-1 - Age > 18 years of age. - Required initial laboratory values: - ANC > 1500/ul - Platelet count > 100,000/mm3 - Creatinine < 2.0 mg/dl - Serum PSA < 100 ng/ml - Bilirubin < upper institutional limit of normal (ULN) - AST/ALT < 2.5 X ULN Exclusion Criteria: - Active or uncontrolled infection. - Patients must not have other coexistent medical condition that would preclude protocol therapy. - Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil). - Grade 1 or greater neuropathy (motor or sensory) at study entry


NCT ID:

NCT00828308


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Providence, Rhode Island 02906
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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