Irinotecan and Cetuximab in Treating Patients With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the breast
• * Clinical manifestations of metastatic disease
• If patient's tumor is HER2 positive (3+ by immunohistochemistry \[IHC\] or amplified by fluorescent in situ hybridization \[FISH\]), must have received at least one prior trastuzumab (Herceptin)-containing regimen unless there is a contraindication
• Measurable disease defined as at least one lesion whose longest diameter can be accurately measured
• * The only evidence of metastasis must not be bone metastases or other non-measurable disease
• * Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter \< 2 cm) and truly nonmeasurable lesions which include any of the following:
• * Bone lesions
• * Leptomeningeal disease
• * Ascites
• * Pleural/pericardial effusion
• * Inflammatory breast disease
• * Lymphangitis cutis/pulmonis
• * Cystic lesions
• * Abdominal masses that are not confirmed and followed by imaging techniques
• No known CNS metastasis unless controlled by prior surgery and/or radiotherapy
• * To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry
• Hormone receptor status
• * Not specified
• PATIENT CHARACTERISTICS:
• Men or women
• Menopausal status not specified
• ECOG performance status 0-2
• Life expectancy \> 3 months
• Hemoglobin \> 8.0 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin normal
• AST and ALT ≤ 5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must employ adequate contraception (as determined by the treating physician) during treatment and for 30 days after treatment ends
• Disease-free for ≥ 3 years of other invasive non-breast malignancies (exception: curatively treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
• No history of allergy or hypersensitivity to drug product excipients, murine antibodies, or agents chemically similar to irinotecan and/or cetuximab
• No history or evidence of Gilbert's syndrome
• No active, unresolved infection
• No New York Heart Association class III or IV cardiovascular disease
• No serious concomitant medical condition that would make it undesirable for patient to participate in the trial or would jeopardize compliance with protocol treatment
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No more than 2 prior chemotherapy regimens in the metastatic setting (irrespective of hormonal therapy or prior trastuzumab therapy)
• * Prior treatment in the metastatic or adjuvant setting must have included an anthracycline or a taxane
• No major surgery ≤ 3 weeks prior to registration
• No chemotherapy ≤ 2 weeks prior to registration
• No radiotherapy ≤ 4 weeks prior to registration
• No prior irinotecan hydrochloride
• No prior therapy with an epidermal growth factor receptor (EGFR) antagonist (either monoclonal antibody or tyrosine kinase inhibitor), such as gefitinib or erlotinib
• No prior therapy with a dual EGFR/HER2 inhibitor (e.g., lapatinib)
• No concurrent interleukin-11(oprelvekin)
• Routine use of granulocyte colony stimulating factors (CSFs) is not permitted during course 1 of this study
• * Subsequent use of CSFs is permitted at the discretion of the treating investigator
• No other concurrent antitumor therapy