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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Docetaxel; Leuprolide; Testosterone

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.