PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer
PRIMARY OBJECTIVES: I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic breast cancer. SECONDARY OBJECTIVES: I. Determine the clinical activity of this drug, in terms of progression-free survival, in these women. II. Determine the toxicity profile and tolerability of this drug in these women. III. Determine the pharmacodynamics of this drug in these women. OUTLINE: Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Correlative studies
M D Anderson Cancer Center
Houston, Texas, United States
Objective tumor response (CR + PR)
The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).
Time frame: Up to 24 months
Time to progression
Will be reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Time frame: Up to 3 years
Overall survival
Will be reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Time frame: Up to 3 years
Correlation between variations in the serum levels of adhesion molecules and angiogenic factors
Will be evaluated and descriptive analysis will be performed.
Time frame: Up to 24 months
Tissue markers of biological activity
Will be described in case of lesions amenable to tissue biopsy. The plasma pharmacodynamics of PS-341 as measured by the 20S-proteosome assay, will be used to measured the biological activity of the drug and correlated with response to treatment and variations in biomarkers.
Time frame: Up to 24 months
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