Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed advanced colorectal cancer
• Disease progression while receiving an irinotecan-containing regimen for metastatic colorectal cancer OR
• Disease recurrence within 6 months after completing an irinotecan-containing regimen in the adjuvant setting
• At least 1 measurable lesion (for phase II only)
• * At least 20 mm by x-ray, CT scan, MRI, or photograph
• * Recurrent disease after surgery or radiotherapy is considered measurable if it has been at least 4 weeks since treatment and measurable disease is outside the port of prior radiotherapy or there is evidence of disease progression within the port of prior radiotherapy
• * The following are not considered measurable:
• * Pleural effusion
• * Ascites
• * Osteoblastic lesion or evidence of disease on bone scan alone
• * Progressive irradiated lesions alone
• * Bone marrow involvement
• * Brain metastases
• * Malignant hepatomegaly by physical exam alone
• * Chemical markers (e.g., carcinoembryonic antigen)
• No known brain metastases or primary brain tumors
• No symptomatic pleural effusion or ascites requiring paracentesis
• No clinical evidence of bowel obstruction
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• ECOG 0-1
• Life expectancy:
• Not specified
• Hematopoietic:
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin greater than 10.0 g/dL
• Hepatic:
• Bilirubin no greater than 2.0 mg/dL
• AST/ALT no greater than 5 times upper limit of normal (ULN)
• PT/PTT less than ULN OR
• INR less than 1.12
• No hepatitis virus infection
• Renal:
• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance greater than 50 mL/min
• Cardiovascular:
• No prior myocardial infarction
• No angina
• No uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg)
• No prior cerebrovascular accident or transient ischemic attack
• Pulmonary:
• No respiratory insufficiency requiring oxygen treatment
• No lymphangitic involvement of lungs
• Other:
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for 30 days before, during, and for 30 days after study
• Thyroxine and thyroid-stimulating hormone normal
• No hematemesis, melena, hematochezia, or gross hematuria
• No prior significant adverse reaction to a humanized monoclonal antibody
• No known HIV infection
• No active infection requiring systemic anti-infective therapy
• No other medical or psychological condition or behavior, including substance dependence or abuse, that would preclude study
• No other malignancy within the past 5 years except basal cell skin cancer or completely excised carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Prior immunotherapy with approved agents allowed
• No prior monoclonal antibody anti-anb3 integrin or its precursor (MEDI-523)
• No other concurrent immunotherapy
• Chemotherapy:
• See Disease Characteristics
• At least 4 weeks since prior chemotherapy
• No concurrent palliative chemotherapy
• Endocrine therapy:
• No concurrent hormonal therapy
• Radiotherapy:
• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• Surgery:
• See Disease Characteristics
• At least 4 weeks since prior surgery and surgical wounds must have healed
• Other:
• Recovered from all prior therapy
• At least 4 weeks since prior investigational agents