A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Metastatic or Recurrent Breast Carcinoma
Inclusion 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