NCT00039273CompletedPhase 2
An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma
Jonsson Comprehensive Cancer Center1 site in 1 country44 target enrollmentStarted: July 1, 2002Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 44
- Locations
- 1
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,500/mm3
- •Platelet count greater than 100,000/mm3
- •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
- •Creatinine no greater than 2.2 mg/dL
- •Cardiovascular:
- •LVEF at least 45% by MUGA
- •No myocardial infarction within the past year
- •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
- •Not specified
- •At least 30 days since other prior anticancer therapy
- •No prior investigational drug with potential antitumor activity
- •No other concurrent investigational drugs
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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