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