Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

03-076

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

2003-07-01

2008-02-01

2008-02-01

Completed

Early phase I

102

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 102, 'type': 'ACTUAL'}}

2023-11-07