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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: GnRh (Leuprolide)

Drug: Testosterone Gel

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00587431

03-076

Details and patient eligibility

About

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

Enrollment

102 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.