Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00483405
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Meets 1 of the following criteria:
* Histologically confirmed hepatocellular carcinoma
* Alpha-fetoprotein (AFP) \> 400 ng/mL with compatible mass by CT scan or MRI
* Metastatic disease OR not a candidate for surgical resection or immediate liver transplantation
* At least 1 site of measurable disease OR evaluable disease (AFP 2 times upper limit of normal (ULN))
* No evidence of central nervous system (CNS) metastases (unless CNS metastases stable for \> 3 months)
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Absolute neutrophil count (ANC) ≥ 1,500/mm³
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 3 times ULN
* International normalized ratio (INR) ≤ 1.5
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN
* Creatinine clearance \> 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known hypersensitivity to capecitabine, cetuximab, or oxaliplatin or to other murine products
* No comorbid condition which is deemed by the investigator to have a life expectancy of \< 6 months
* No New York Heart Association class III-IV coronary artery disease and/or heart failure
* No variceal bleeding within the past 60 days
* No other cancer within the past 5 years except cervical intraepithelial neoplasia, nonmelanoma skin cancer, ductal carcinoma in situ, chronic lymphocytic leukemia, or treated localized prostate cancer with a normal prostate specific antigen level
* No active drug or alcohol abuse
* No prior allergic reaction to a therapeutic antibody
* No serious, uncontrolled infection
* No history of uncontrolled seizures, CNS disorders, or psychiatric disability that, in the opinion of the investigator, would preclude study participation or compliance
* No other serious uncontrolled medical condition that, in the opinion of the investigator, would preclude study participation
* No lack of physical integrity of the upper gastrointestinal tract
* No malabsorption syndrome
* No known existing uncontrolled coagulopathy
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior participation in an investigational drug trial
* At least 4 weeks since prior major surgery and recovered
* At least 4 weeks since prior embolization, resection, or ablation
* No prior epidermal growth factor receptor (EGFR)-targeting therapy
* No prior systemic chemotherapy or hepatic artery infusion of chemotherapy
* No concurrent phenytoin
* No concurrent therapeutic warfarin
* Low-dose non-therapeutic warfarin to maintain patency of venous access devices allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00483405
Study Brief:
Protocol Section:
NCT00483405