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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GnRh (Leuprolide)
Testosterone Gel
Docetaxel
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, Cancer, Docetaxel, 03-076

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

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

Secondary Outcome Measures

The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
Docetaxel Pharmacokinetic parameters for cycles 1 and 2.

Full Information

First Posted
December 21, 2007
Last Updated
August 5, 2014
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00587431
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Cancer, Docetaxel, 03-076

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
GnRh (Leuprolide)
Other Intervention Name(s)
22.5 mg intramuscular injection
Intervention Description
Leuprolide LUPRON
Intervention Type
Drug
Intervention Name(s)
Testosterone Gel
Other Intervention Name(s)
AndroGel
Intervention Description
Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
70 mg/m2 given on day o1 of each 3 week cycle
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
Description
Docetaxel Pharmacokinetic parameters for cycles 1 and 2.
Time Frame
at Cycle 1 and 2

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Rathkopf, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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

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