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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer  Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): Seattle Genetics ,
Synopsis: 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.
Details: OBJECTIVES: I. Determine the toxicity and safety profile of doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) and docetaxel in women with metastatic or recurrent breast cancer. II. Determine the clinical response rate and duration of response of patients treated with this regimen. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 Measurable disease OR 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 --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 --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/mm3 - Platelet count at least 100,000/mm3 - 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LisleNabell, Study Chair, Seattle Genetics
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Additional Information:
Study ID Numbers: CDR0000069079; UAB-9912,SGEN-UAB-9912
Study Start Date: October 2000
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028483
Other Recurrent Breast Cancer Studies:
1. Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
2. Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
3. Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
5. Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
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