Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
- 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
- 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
- Peripheral neuropathy >_ grade 3.
- Patients with a history of severe hypersensitivity reaction to drugs formulated with
- 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
- Prior chemotherapy
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital,
St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.