Irinotecan and Cetuximab in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria

• •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