Expired Study
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Birmingham, Alabama 35294


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and monoclonal antibody therapy in treating women who have metastatic or recurrent breast cancer.


Study summary:

OBJECTIVES: - Determine the toxicity and safety profile of doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) and docetaxel in women with metastatic or recurrent breast cancer. - Determine the clinical response rate and duration of response of patients treated with this regimen. OUTLINE: Patients receive doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) IV over 2 hours and docetaxel IV over 30 minutes on day 1 of weeks 1-6. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 18-24 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic or recurrent breast carcinoma - Unresectable disease - Previously treated with no more than 2 chemotherapy regimens for metastatic disease OR - Recurrent within 6 months of adjuvant chemotherapy - Must have one of the following: - Measurable disease - Positive bone scan and elevation of serum tumor marker for adenocarcinoma - Serum levels must have increased over 2 consecutive measurements and exceed at least 2 times upper limit of normal - Lewis-y antigen expression documented by immunohistochemistry - No brain metastases that are uncontrolled or require active treatment (including steroids) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Hemoglobin at least 10 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding diathesis Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 2.5 times normal - Alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis present) - Amylase/lipase less than 1.5 times normal - Hepatitis B and C negative - No hepatic failure Renal: - Creatinine no greater than 1.5 times upper limit of normal - No renal failure Cardiovascular: - LVEF greater than 50% by echocardiogram or MUGA scan - No congestive heart failure Other: - HIV negative - No antibody present that detects monoclonal antibody BR96 in serum - No peripheral neuropathy grade 2 or greater - No dementia or altered mental status - No other serious underlying medical condition that would preclude study participation - No prior allergic reactions to recombinant human or murine proteins - No uncontrolled peptic ulcer disease - No active viral, bacterial, or systemic fungal infections - No other primary malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix - No serious nonmalignant disease - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 8 weeks since prior therapeutic or diagnostic murine/humanized/human chimeric antibodies Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, mitomycin, or anthracyclines) - No prior cumulative anthracycline of 300 mg/m2 or more - No concurrent antineoplastic agents Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior hormonal therapy - No concurrent hormonal therapy except estrogen replacement Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics Other: - No other concurrent experimental agents - No concurrent immunosuppressive medications


NCT ID:

NCT00028483


Primary Contact:

Study Chair
Lisle M. Nabell, MD
University of Alabama at Birmingham


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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