Expired Study
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New York, New York 10065


Purpose:

We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.


Criteria:

Inclusion Criteria: - Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC. - Patient must have a serum testosterone > 180 ng/dl. - Karnofsky performance status (KPS)>_70%. - Patients must have adequate organ function as defined by the following - laboratory criteria: - WBC >_ 3500/mm3 - ANC >_1500/mm3 - Platelet count >100,000/mm3 - Hemoglobin >8.0g/dL - Creatinine <1.6mg/dl - Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL) - SGOT and SGPT If alkaline phosphatase is _< 2.5 x ULN, any elevations in - AST/ALT; OR if AST/ALT is _<1.5 x ULN, any elevation in alkaline phos - Prior hormonal therapy is allowed as: 1. Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy). 2. One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy). - Patients must be at least 18 years of age. - Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment Exclusion Criteria: - Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease. - Uncontrolled serious active infection. - Anticipated survival of less than 3 months. - Active CNS or epiduraltumor - Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests - Peripheral neuropathy >_ grade 3. - Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80. - Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment. - Prior chemotherapy - Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.


NCT ID:

NCT00587431


Primary Contact:

Principal Investigator
Dana Rathkopf, MD, PhD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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