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PS-341 in Treating Women With Metastatic Breast Cancer



PS-341 in Treating Women With Metastatic Breast Cancer

For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WilliamGradishar,  Study Chair,  Robert H. Lurie Cancer Center

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 


Additional Information:
Study ID Numbers:  CDR0000069114;  NU-NCI00B11,NCI-1862
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028639

Other Stage 4 Breast Cancer Studies:
1. Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer

2. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer

3. Biological Therapy in Treating Patients With Advanced Cancer

4. Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer

5. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer

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