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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00587431
First received: December 21, 2007
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: GnRh (Leuprolide)
Drug: Testosterone Gel
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: Conclusion of the study (at 6 months then at 18 months post-treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Effects of Testosterone Administration on Docetaxel Pharmacokinetics. [ Time Frame: at Cycle 1 and 2 ] [ Designated as safety issue: No ]
    Docetaxel Pharmacokinetic parameters for cycles 1 and 2.


Enrollment: 102
Study Start Date: July 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: GnRh (Leuprolide)
Leuprolide LUPRON
Other Name: 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 Name: AndroGel
Drug: Docetaxel
70 mg/m2 given on day o1 of each 3 week cycle
Other Name: Taxotere
Active Comparator: 2 Drug: GnRh (Leuprolide)
Leuprolide LUPRON
Other Name: 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 Name: AndroGel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00587431

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Dana Rathkopf, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00587431     History of Changes
Obsolete Identifiers: NCT00070369
Other Study ID Numbers: 03-076
Study First Received: December 21, 2007
Results First Received: January 21, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Prostate
Cancer
Docetaxel
03-076

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Leuprolide
Docetaxel
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014