Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan, leucovorin, and fluorouracil with ABX-EGF in treating patients who have metastatic colorectal cancer.


Study summary:

OBJECTIVES: - Determine progression-free survival of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF, irinotecan, leucovorin calcium, and fluorouracil. - Determine additional measures of clinical efficacy of this regimen in these patients. - Determine the safety of this regimen in these patients. - Determine the pharmacokinetics of monoclonal antibody ABX-EGF when administered with this regimen in these patients. - Determine the pharmacokinetics of irinotecan and its active metabolite SN-38 when administered with this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody ABX-EGF IV over 1 hour, irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV over 5 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed within 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed colorectal cancer - Metastatic disease - Must have been free of disease for at least 1 year if received prior adjuvant fluorouracil - Epidermal growth factor receptor (EGFR) over-expression by immunochemistry (staining 2+ or 3+ in at least 10% of tumor cells) - Unidimensionally measurable disease - No clinically significant ascites or pleural effusion - No known brain metastases 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 Hepatic - Bilirubin no greater than 2.0 mg/dL - AST and ALT no greater than 3 times upper limit of normal Renal - Creatinine no greater than 2.2 mg/dL Cardiovascular - LVEF at least 45% by MUGA - No myocardial infarction within the past year Other - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study participation - No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix - No chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior irinotecan Endocrine therapy - Not specified Radiotherapy - No prior or concurrent radiotherapy for colorectal cancer Surgery - Prior surgery for colorectal cancer allowed Other - At least 30 days since prior investigational drugs - No other prior therapy for colorectal cancer - No prior therapy for metastatic disease - No prior EGFR-targeting agents - No concurrent prochlorperazine during days 1-29 of each study course - No other concurrent EGFR-targeting agents - No other concurrent investigational drugs - No other concurrent therapy for colorectal cancer - No concurrent investigational supportive care therapy


NCT ID:

NCT00047151


Primary Contact:

Principal Investigator
Joel Randolph Hecht, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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