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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: GnRh (Leuprolide); Drug: Testosterone Gel; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: GnRh (Leuprolide); Leuprolide LUPRON; Other Names: 22.5 mg intramuscular injection; Drug: Testosterone Gel; Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p); Other Names: AndroGel; Drug: Docetaxel; 70 mg/m2 given on day o1 of each 3 week cycle; Other Names: Taxotere
Active Comparator: 2	Drug: GnRh (Leuprolide); Leuprolide LUPRON; Other Names: 22.5 mg intramuscular injection; Drug: Testosterone Gel; Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p); Other Names: AndroGel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy	Conclusion of the study (at 6 months then at 18 months post-treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.	Docetaxel Pharmacokinetic parameters for cycles 1 and 2.	at Cycle 1 and 2

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Dana Rathkopf, MD, PhD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: January 4, 2008
• First Posted (Estimated): January 7, 2008

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Docetaxel; Cancer; Prostate; 03-076
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Androgens; Docetaxel; Leuprolide; Testosterone
• Other Study ID Numbers: 03-076