Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00006044
First received: July 5, 2000
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that no longer respond to hormone therapy.

PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: therapeutic testosterone
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer

Resource links provided by NLM:


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

Study Start Date: February 2000
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the safety and maximum tolerated dose of exogenously administered testosterone in patients with progressive androgen-independent prostate cancer who have been in castrate state either surgically or pharmacologically for a minimum of 1 year.
  • Assess the changes in expression of androgen receptor and other receptors in human biopsy specimens or circulating tumor cells before and after this treatment in this patient population.

OUTLINE: This is a dose-escalation study.

Patients receive testosterone via an enhanced absorption transdermal system continuously for 28 days. The transdermal patches are changed daily.

Cohorts of 3-6 patients receive a fixed daily dose of testosterone with escalating duration of exposure until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.

Patients are followed at day 1 and at weeks 2 and 4.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed androgen independent metastatic prostate cancer
  • Progressive disease manifested by either:

    • New osseous lesions by bone scan or a greater than 25% increase in bidimensionally measurable soft tissue disease or the appearance of new sites of disease by MRI or CT scan OR
    • Minimum of 3 rising PSA values from baseline that are obtained 1 week or more apart, or 2 rising PSA values more than 1 month apart, where the percentage increase over the range of values is at least 25%
  • Castrate state by orchiectomy or gonadotropin-releasing hormone analogues for minimum of 1 year

    • Testosterone no greater than 30 ng/mL
  • Measurable disease
  • Metastatic disease by bone scan, MRI, or CT scan
  • Rising PSA values
  • If receiving antiandrogen therapy, must have shown progressive disease off treatment
  • No active CNS or epidural tumor

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • SGOT less than 3 times upper limit of normal
  • PTT less than 14 seconds

Renal:

  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

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

Pulmonary:

  • No severe debilitating pulmonary disease

Other:

  • No infection requiring IV antibiotics
  • No other severe medical problems that would increase risk for toxicity

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Recovered from prior biologic therapy
  • No concurrent immunotherapy

Chemotherapy:

  • Recovered from prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • If no prior orchiectomy, must continue on gonadotropin-releasing hormone analogs to maintain castrate levels of testosterone
  • No concurrent finasteride
  • No other concurrent hormonal therapy

Radiotherapy:

  • Recovered from prior radiotherapy
  • No concurrent radiotherapy to an indicator lesion

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery
  • No concurrent surgery on only measurable lesion

Other:

  • At least 4 weeks since other prior investigational anticancer drugs and recovered
  • No other concurrent investigational anticancer agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006044

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Michael Morris, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006044     History of Changes
Other Study ID Numbers: 99-115, P30CA008748, P01CA005826, MSKCC-99115, NCI-G00-1818
Study First Received: July 5, 2000
Last Updated: January 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage IV prostate cancer
recurrent prostate cancer

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
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 18, 2014