Expired Study
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Los Angeles, California 90095


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 II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer.


Study summary:

OBJECTIVES: - Determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF. - Determine the additional measures of clinical efficacy of this drug, in terms of progression-free survival, overall survival, and time to treatment failure, in these patients. - Determine the safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed colorectal carcinoma - Diagnosed by fine-needle aspirate or tissue biopsy - Metastatic disease - No squamous cell carcinoma - Relapsed or refractory after prior chemotherapy with irinotecan and a fluoropyrimidine (i.e., fluorouracil, capecitabine, or ftorafur with or without leucovorin calcium) given concurrently or sequentially - Progressive disease within 2 months of last dose of this prior chemotherapy for metastatic disease OR - Evidence of relapse within 12 months after last dose of adjuvant therapy - Bidimensionally measurable disease - Overexpression of epidermal growth factor r (EGFr) by immunohistochemistry - Must be 2+ or 3+ in at least 10% of evaluated tumor cells - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,500/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN 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 - 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 that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior EGFr-targeting agents or biological agents with antitumor activity Chemotherapy: - See Disease Characteristics - At least 30 days since prior systemic chemotherapy - No more than 2 prior fluoropyrimidine regimens (e.g., fluorouracil and leucovorin calcium followed by capecitabine) - No other prior chemotherapy, except leucovorin calcium, for colorectal carcinoma Endocrine therapy: - Not specified Radiotherapy: - At least 30 days since prior radiotherapy Surgery: - Not specified Other: - At least 30 days since other prior anticancer therapy - No prior investigational drug with potential antitumor activity - No other concurrent investigational drugs


NCT ID:

NCT00039273


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: December 12, 2017

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