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

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.

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 Investigator: Memorial Sloan-Kettering Cancer Center Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 09, 2012

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