Official Title: “Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: GnRh (Leuprolide)
  • Leuprolide LUPRON
• Drug: Testosterone Gel
  • Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)
• Drug: Docetaxel
  • 70 mg/m2 given on day o1 of each 3 week cycle

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• PSA of <_ 0.05 ng/ml after radical prostatectomy or radiation therapy and PSA <_ 2.0 ng/ml for patients with clincal metastases without prior definitive therapy
  • Time Frame: Conclusion of the study
    Safety Issue?: No

Secondary Measures

• To assess the safety of rapid hormonal cycling, Androgel and docetaxel
  • Time Frame: Conclusion of study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Dana Rathkopf, MD, PhD Principal Investigator Memorial Sloan-Kettering Cancer Center  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00587431

Study ID Number: 03-076

ClinicalTrials.gov Identifier: NCT00587431

Health Authority: United States: Institutional Review Board