Title
Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Metastatic or Recurrent Breast Carcinoma
Phase
Phase 2Lead Sponsor
Seattle GeneticsStudy Type
InterventionalStatus
TerminatedIndication/Condition
Breast CancerStudy Participants
NoneRATIONALE: 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.
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.
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
