Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

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