Expired Study
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Chicago, Illinois 60611


Purpose:

RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer.


Study summary:

OBJECTIVES: - Determine the objective tumor response in women with metastatic breast cancer treated with bortezomib. - Determine the toxic effects of this drug in these patients. - Determine the progression-free survival in patients treated with this drug. OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 6-24 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Metastatic disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - Previously treated with 1 prior chemotherapy regimen (with or without trastuzumab [Herceptin]) for metastatic disease - Relapse during or within 6 months after completion of adjuvant chemotherapy considered treatment failure - No known brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - No uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study - No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib - No other prior malignancy within the past 5 years unless curatively treated and disease free - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - Prior hormonal therapy for metastatic disease allowed - At least 4 weeks since prior hormonal therapy and recovered Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - Prior adjuvant therapy allowed - At least 4 weeks since prior investigational drugs and recovered - No other concurrent investigational or commercial agents or therapies for breast cancer - No concurrent combination antiretroviral therapy for HIV


NCT ID:

NCT00028639


Primary Contact:

Study Chair
William J. Gradishar, MD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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