Phase II Trial of Concurrent Irinotecan Plus Cetuximab in Patients With Advanced Breast Cancer With Prior Anthracycline and/or Taxane-Containing Therapy
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