Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center