17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Hormone-Refractory Metastatic Prostate Cancer|
- PSA response as defined by the recommendations of the Prostate-Specific Antigen Working Group [ Time Frame: Up to 1 year ]
- Proportion of overall responses [ Time Frame: Up to 3 years ]The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
- Overall survival [ Time Frame: From registration to death due to any cause, assessed up to 3 years ]The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Disease-free survival [ Time Frame: From registration to documentation of disease progression, assessed up to 3 years ]The distribution of disease-free survival time will be estimated using the method of Kaplan-Meier.
- Clinical or radiographic response rate (partial response [PR] and complete response [CR]) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 3 years ]The number of patients with a PR or CR will be divided by the total number of evaluable patients with measurable disease. Assuming that this response incidence is binomially distributed, exact 95% confidence intervals will also be calculated.
- Duration of PSA response and PSA control [ Time Frame: From PSA response to time of progression, assessed up to 1 year ]The distribution of this response duration will be estimated using the method of Kaplan-Meier.
- Change in expression levels of interleukin-6 (IL-6), maspin and NF-kappaB [ Time Frame: From baseline to up to 3 years ]Summarized descriptively both quantitatively and graphically. Each of these correlative endpoints will be summarized individually, but will also be evaluated in terms of their relationships to one another; i.e. using Spearman rank correlation coefficient to assess the correlations between the three markers.
- Correlation of biomarkers with cancer and treatment-related outcomes [ Time Frame: Up to 3 years ]Relationships will also be explored graphically using scatter plots.
- Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 30 days after completion of treatment ]
|Study Start Date:||January 2005|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Experimental: Treatment (tanespimycin)
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.
Given IVOther: laboratory biomarker analysis
I. Determine the prostate-specific antigen (PSA) response in patients with hormone-refractory metastatic prostate cancer treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).
I. Determine the overall survival and disease-free survival rate in patients treated with this drug.
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118092
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Elisabeth Heath||Mayo Clinic|