Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: GnRh (Leuprolide); Testosterone Gel; Docetaxel
Intervention description: Leuprolide LUPRON; Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p); 70 mg/m2 given on day o1 of each 3 week cycle
Intervention MeSH terms: Docetaxel; Leuprolide; Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate; Cancer; Docetaxel; 03-076

Summary:

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

Eligibility 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.