Colon Cancer Clinical Trial
Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
Los Angeles California, 90095, United States
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