Cetuximab and Irinotecan in Treating Patients With Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven refractory advanced colorectal carcinoma Must have 1 of the following: Stable disease after receiving a minimum of 12 weeks of irinotecan Disease progression at any time after receiving an irinotecan containing regimen No prior chemotherapy for colorectal carcinoma during the interval between the irinotecan containing regimen and study entry Bidimensionally measurable disease Index lesions must be outside prior radiation ports Epidermal growth factor receptor (EGFr) expression (1+ or greater) must be confirmed prior to study entry Patients who have no tumor tissue available for immunohistochemical assay of EGFr testing undergo biopsy of accessible tumor No meningeal or CNS involvement by tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN ALT and AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No clinically significant cardiac disease No serious arrhythmias No significant conduction abnormalities Neurologic: No uncontrolled seizure disorder No active neurologic disease No grade 2 or worse neuropathy Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy or cetuximab Chemotherapy: See Disease Characteristics Recovered from any toxicities No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 months since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery except diagnostic biopsy Other: At least 1 month since prior investigational agents
Sites / Locations
Arms of the Study
Arm 1
Experimental
EgFR antibody