Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer that has not responded to irinotecan.


Study summary:

OBJECTIVES: - Determine the recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with irinotecan-refractory advanced colorectal cancer. - Determine the safety and tolerance of this drug in these patients. - Determine any antitumor activity of this drug in these patients. - Determine the objective response rate, response duration, and time to progression in patients treated with this drug. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes once weekly on weeks 1-52 in the absence of disease progression or unacceptable toxicity. Patients with responding disease may continue therapy. Cohort of 4-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose in the phase II portion of the study. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 4-24 patients will be accrued for phase I of this study and a total of 40 patients will be accrued for phase II of this study.


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


NCT ID:

NCT00027729


Primary Contact:

Study Chair
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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