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Docetaxel With Rapid Hormonal Cycling As A Treatment For Patients With Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Docetaxel With Rapid Hormonal Cycling As A Treatment For Patients With Prostate Cancer



- Determine the efficacy of rapid hormonal cycling with testosterone and leuprolide in
combination with docetaxel, in terms of obtaining a durable decline in
prostate-specific antigen level or reduction of abnormal sites of disease, in patients
with recurrent or non-castrate metastatic adenocarcinoma of the prostate.


- Determine the safety of this regimen in these patients.

- Determine the antitumor effects and changes in measurable disease in patients treated
with this regimen.

- Determine the affects of testosterone administration on CYP3A activity and docetaxel
pharmacokinetics in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical state
(rising prostate-specific antigen vs non-castrate metastatic disease).

Patients receive leuprolide intramuscularly and docetaxel IV over 1 hour on day 1 and
testosterone gel topically on days 22-28. Treatment repeats every 28 days for 6 courses* in
the absence of disease progression or unacceptable toxicity.

NOTE: *Testosterone gel is applied only during courses 1-5.

Patients are followed monthly for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 76 patients (38 per stratum) will be accrued for this study
within approximately 2 years.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate in either of the following
clinical states:

- History of localized disease with prior definitive radiotherapy or surgery

- Biochemically progressive disease*

- No radiographically evident disease

- Radiographically evident non-castrate metastatic disease at the time of
diagnosis or after treatment for localized disease

- Radiographically (new osseous lesions or more than a 25% increase in a
bidimensionally measurable tumor mass) AND/OR biochemically progressive

- Testosterone greater than 180 mg/dL

- No active CNS or epidural tumor NOTE: *Biochemically progressive disease, defined as
an increase of at least 50% in the prostate-specific antigen (PSA) level across at
least 3 determinations each measured more than 2 weeks apart with a baseline PSA of
at least 2 ng/mL



- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- At least 3 months


- WBC at least 3,500/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin greater than 8.0 g/dL


- Bilirubin normal

- SGOT and SGPT less than 2.5 times upper limit of normal (ULN) AND alkaline
phosphatase less than ULN OR

- Alkaline phosphatase no greater than 4 times ULN AND SGPT and SGOT less than ULN


- Creatinine no greater than 1.6 mg/dL OR

- Creatinine clearance at least 60 mL/min


- No New York Heart Association class III or IV cardiac disease


- No severe debilitating pulmonary disease


- Fertile patients must use effective contraception during and for at least 6 months
after study treatment

- No uncontrolled serious active infection

- No grade 2 or greater peripheral neuropathy

- No prior severe hypersensitivity reaction to drugs formulated with polysorbate 80


Biologic therapy

- No concurrent immunotherapy


- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Prior hormonal therapy before radiotherapy or radical prostatectomy allowed provided
the total duration of therapy is no more than 6 months

- No more than 1 course of intermittent hormonal therapy up to a maximum exposure of 6


- See Disease Characteristics

- No concurrent therapeutic radiotherapy


- See Disease Characteristics


- At least 7 days since prior inhibitors or inducers of CYP3A, including the following:

- Fluconazole

- Itraconazole

- Macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin, and

- Midazolam

- Nifedipine

- Uncaria tomentosa (cat's claw)

- Chamomile (matricaria chamomila)

- Echinacea

- Hydrastis canadensis (Goldenseal)

- Glycyrrhiza glabra (licorice)

- Milk thistle

- Trifolium pratense (wild cherry)

- Garlic

- No concurrent inhibitors or inducers of CYP3A during courses 1 and 2

- No concurrent administration of the following drugs:

- Phenytoin

- Carbamazepine

- Barbiturates

- Rifampin

- Phenobarbital

- Hypericum perforatum (St. John's wort)

- Ketoconazole

- No other concurrent experimental anticancer medication

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA ≤ 0.05 ng/mL after radical prostatectomy

Safety Issue:


Principal Investigator

Dana Rathkopf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410