Clinical trial NCT00275041 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: irinotecan hydrochloride
SMILES: CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12
Eligibility 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