Phase II Study of Celecoxib in HER-2/Neu Overexpressing Metastatic Breast Cancer Patients Who Have Failed Recombinant Humanized Anti-p 185HER Monoclonal Antibody Trastuzumab (HERCEPTIN)
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven metastatic breast cancer
- HER2/neu-positive (overexpressing) tumor tissue
- Failed prior trastuzumab (Herceptin) therapy with or without chemotherapy
- Resected stage IV disease allowed if evidence of disease
- Bidimensionally measurable or evaluable disease
- No lesions in previously irradiated field except nonbone lesions progressive
after radiotherapy
- No pleural effusions
- No blastic or mixed bony metastases
- No palpable abdominal masses
- No leptomeningeal disease
- Brain metastases allowed if:
- No concurrent use of steroids
- At least 3 months since prior brain irradiation
- No evidence of progression of metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Hemoglobin at least 8.0 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- AST/ALT no greater than 2 times upper limit of normal (ULN)
- Bilirubin no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- LVEF at least 50%
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No other prior malignancy within the past 5 years except adequately treated carcinoma
in situ of the cervix or nonmelanoma skin cancer
- No other serious medical illness
- No severe infection
- No severe malnutrition
- No prior allergic reactions to sulfonamides or celecoxib
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- Prior trastuzumab (Herceptin) for breast cancer allowed, either as
adjuvant/neoadjuvant or for metastatic disease
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered
- Prior cytotoxic therapy for breast cancer allowed, either as adjuvant/neoadjuvant or
for metastatic disease
Endocrine therapy:
- See Disease Characteristics
- At least 3 weeks since prior hormonal therapy
- Prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy
allowed
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- Prior localized radiotherapy allowed if no influence on the signal measurable lesion
- Concurrent localized radiotherapy allowed if no influence on the signal measurable
lesion
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior major surgery and recovered
- At least 2 weeks since prior minor surgery and recovered