10.1 Toxicities to be graded at each evaluation and pre-treatment 
symptoms /conditions to be evaluated at baseline per WHO Criteria: 
Toxicity /symptoms 
Baseline 
Each Evaluation 
Fatigue 
X 
X 
Weight loss/anorexia 
X 
X 
Nausea 
X 
X 
Vomiting 
X 
X 
Hemorrhage 
X 
Infection 
X 
Liver (SGOT, alk phos, 
and total bilirubin) 
X 
X 
11.0 Treatment Evaluation 
11.1 Patients will be evaluated by a Mayo Clinic medical oncologist at least 
every 4 weeks while receiving treatment, every 8 weeks until there is 
evidence of tumor progression, and then 8-12 week intervals thereafter as 
long as the patient is able to return to the Mayo Clinic. 
11.2 Evaluation of tumor regression is a secondary endpoint in this clinical 
trial. The following criteria will apply to measurable indicator lesions 
within the liver or for any measurable extrahepatic lesions that may be 
present. 
11.3 Minimum size requirements for measurable indicator lesions: 
11.3.1 Tumor masses with clearly defined bidimensional measurements. 
The minimum size of the indicator lesion depends on the method 
of measurement as follows: 
Minimum Size of 
Method of Measurement Largest Tumor Diameter 
Physical examination or chest x-ray 
(discrete lesion that can be measured 
with calipers) 1.0cm 
CT Scan* 3.0cm 
*Note: Special attention should be paid to identify the specific 
lesion being measured, and to define an anatomic landmark 
to identify the level of the cross-sectional image to facilitate 
serial measurements. Lesions 2. 0-3.0 cm in diameter may be 
used as indicator lesions if serial images are obtained at 0.5 
cm intervals through the tumor. 
11.4 Criteria for a partial response (PR) 
11.4.1 bidimensional indicator lesion(s) 
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Recombinant DNA Research, Volume 18 
