A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Hormone-Refractory Metastatic Prostate Cancer
I. Determine the prostate-specific antigen (PSA) response in patients with
hormone-refractory metastatic prostate cancer treated with
I. Determine the overall survival and disease-free survival rate in patients treated with
II. Determine the safety profile of this drug in these patients. III. Determine the duration
of PSA response and PSA control in patients treated with this drug.
IV. Determine the partial and complete response rates in patients with measurable disease
treated with this drug.
V. Correlate changes in expression levels of interleukin-6, maspin, and NF-kappaB in serum
and tissue with cancer and treatment-related outcomes in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients who achieve a complete response (CR) receive 2 additional courses of treatment
beyond documentation of CR.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 20
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response as defined by the recommendations of the Prostate-Specific Antigen Working Group
Up to 1 year
United States: Food and Drug Administration
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