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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00118105
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of hepatic metastases secondary to colorectal cancer by percutaneous hepatic biopsy
* Resectable hepatic metastases by any of the following:
* Minor resection (i.e., less than a hemihepatectomy)
* Major resection (i.e., hemihepatectomy or extended hepatectomy)
* Bilobar resection (including atypical resection)
* Synchronous primary tumor and hepatic metastases allowed
* Radiologic evidence of hepatic metastases by multiphasic contrast-enhanced spiral CT scan
* Resectable primary colorectal cancer that is in place allowed
* Measurable disease
* No evidence of extrahepatic metastases by chest x-ray or CT scan of the chest
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin ≥ 9.0 g/dL
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* SGOT or SGPT ≤ 2.5 times ULN
Renal
* Creatinine clearance ≥ 60 mL/min
* Urine protein/creatinine ratio \< 1 OR
* Urine protein \< 1 g by 24-hour urine collection
Cardiovascular
* No uncontrolled hypertension (i.e., blood pressure \> 150/90 mm Hg)
* History of hypertension allowed provided it is well controlled on a stable regimen of anti-hypertensive therapy
* No arterial thromboembolic event within the past 12 months, including any of the following:
* Transient ischemic attack
* Cerebrovascular accident
* Unstable angina
* Myocardial infarction
* No peripheral vascular disease ≥ grade 2
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No pre-existing peripheral neuropathy ≥ grade 2
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* More than 6 months since prior adjuvant chemotherapy for the primary tumor
* No prior systemic chemotherapy for metastatic disease
* No prior hepatic artery infusion chemotherapy for metastatic disease
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for metastatic disease
Surgery
* More than 7 days since prior colonoscopy or fine needle aspiration
* More than 28 days since prior major invasive surgery or open biopsy
Other
* At least 4 weeks since prior and no concurrent sorivudine or brivudine
* No prior radiofrequency ablation for metastatic disease
* No prior cryotherapy for metastatic disease
* No other prior ablative techniques for metastatic disease
* No concurrent cimetidine
* Concurrent ranitidine or other drug from a different antiulcer class allowed
* No concurrent oral anticoagulation for treatment of thrombosis
* Concurrent warfarin (1 mg) to maintain patency of central venous catheter allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00118105
Study Brief:
Protocol Section:
NCT00118105