Monoclonal Antibody Plus Chemotherapy in Treating Patients With Advanced Colorectal Cancer That Overexpresses HER2

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed stage IV colorectal cancer with p185 HER2 overexpression
• Bidimensionally measurable disease Indicator lesion must be outside of irradiated field No symptomatic CNS brain metastases
• PATIENT CHARACTERISTICS:
• Performance status: ECOG 0-2
• Absolute granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 3.0 times ULN
• Creatinine no greater than 2.0 mg/dL
• LVEF at least 45% by MUGA or ECHO
• No myocardial infarction within the past 6 months
• No congestive heart failure
• No unstable angina
• No clinically significant pericardial effusion or arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study
• No other prior malignancy within the past 5 years, except:
• * Curatively treated basal or squamous cell skin cancer
• * Curatively treated carcinoma in situ of the cervix
• * No active serious infection or serious underlying medical condition that would prevent compliance
• * No dementia or significantly altered mental status
• PRIOR CONCURRENT THERAPY:
• Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa allowed
• No prior trastuzumab
• No more than 1 prior chemotherapy regimen for advanced disease (if progressed during or within 6 months of adjuvant therapy considered to have had 1 regimen for advanced disease)
• No prior irinotecan
• Concurrent contraception, estrogen replacement therapy, or megestrol acetate for anorexia allowed
• Greater than 3 weeks since prior radiotherapy and recovered
• Greater than 3 weeks since major surgery (except simple biopsy or venous access placement) and recovered
• At least 3 weeks since prior investigational nonneoplastic drugs