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A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael Morris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-115

NCT ID:

NCT00006044

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021