Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: therapeutic testosterone (Drug); androgen therapy (Procedure); endocrine therapy (Procedure); hormone therapy (Procedure)
Phase: Phase 1
Status: Suspended
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
Michael Morris, MD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center
Summary
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.
Clinical Details
Official title:
A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer
Study design: Interventional, Treatment
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
Minimum age: 18 Years.
Gender(s): Male.
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
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: March 5, 2007
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