Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the breast
• * Metastatic disease
• Previously treated with chemotherapy in the adjuvant setting and/or for metastatic disease
• At least one unidimensionally measurable lesion
• * At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan
• * Superficial clinical lesions (e.g., skin nodules or palpable lymph nodes) are allowed
• * Lesions on chest x-ray are allowed provided they are clearly defined and surrounded by aerated lung
• * The following are not considered measurable:
• * Bone lesions
• * Ascites
• * Leptomeningeal disease
• * Pleural/pericardial effusion
• * Inflammatory breast disease
• * Lymphangitis cutis/pulmonis
• * Cystic lesions
• No known CNS metastases unless controlled by prior surgery and/or radiotherapy
• Hormone receptor status:
• * Estrogen receptor (ER) and/or progesterone receptor (PR) status known
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Male or female
• Menopausal status
• Not specified
• Performance status
• ECOG 0-2
• Life expectancy
• At least 3 months
• Hematopoietic
• Granulocyte count ≥ 1,500/mm\^3
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• Bilirubin ≤ upper limit of normal (ULN)
• Meets 1 of the following criteria:
• * AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN
• * Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN
• * AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
• Renal
• Creatinine ≤ 1.5 times ULN
• Cardiovascular
• No myocardial infarction within the past 180 days
• No congestive heart failure
• No unstable angina
• No clinically significant pericardial effusion or arrhythmias
• Other
• No active, unresolved infection
• No prior severe hypersensitivity reaction to docetaxel, irinotecan, or any drug formulated with polysorbate 80
• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No grade 1 or greater sensory or motor neuropathy
• No other concurrent severe condition that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Prior trastuzumab (Herceptin®) required for HER-2-positive patients (unless contraindicated)
• Chemotherapy
• See Disease Characteristics
• More than 14 days since prior chemotherapy
• No more than 2 prior chemotherapy regimens for metastatic disease
• No prior irinotecan or docetaxel for metastatic disease
• * Docetaxel as adjuvant therapy allowed
• No other concurrent chemotherapy
• Endocrine therapy
• Prior hormonal therapy required for patients with ER- and/or PR-positive tumors (unless contraindicated)
• Radiotherapy
• See Disease Characteristics
• At least 30 days since prior radiotherapy
• No concurrent radiotherapy
• Surgery
• See Disease Characteristics
• At least 3 weeks since prior major surgery and recovered
• Other
• More than 7 days since prior parenteral antibiotic therapy
• No other concurrent experimental drugs