pharmacokinetic substudy will directly address this question); thus, urine 
and stool specimens are anticipated to be negative by Day 3 or earlier. 
7.2 Study Evaluadons, Days 1-3 
These evaluadons will be performed on Day 1 prior to infusion and repeated on 
Days 2 and 3: 
7.2.1 Complete history, physical examinadon, and toxicity evaluadon, including: 
• Performance status. 
• Height and weight, body surface area. 
• Toxicity evaluadon. 
7.2.2 Laboratory tests : 
• CBC with differential, platelet count. 
• Serum electrolytes (sodium, potassium, chloride, bicarbonate), BUN, 
creatinine, glucose, uric acid, albumirf, total protein, calcium, phosphorus, and 
magnesium. 
• AST, ALT, total bilirubin, alkaline phosphatase, LDH. 
• PT, PTT. 
• Urinalysis. 
7.2.3 Special studies 
• Pharmacokinetics (Section 7.7) 
• Immune responses (Section 7.8) 
• Study Serum Bank (Section 7.9) 
7 . 3 Weekly Study Evaluations 
These evaluations will be performed on Days 7, 14, and 21: 
7.3.1 Complete history, physical examination, and toxicity evaluation, as in Section 
7.2.1. 
7.3.2 Laboratory tests, as in Section 7.2.2. 
7.3.3 Special studies 
• Pharmacokinetics (Section 7.7) 
• Immune responses (Section 7.8) 
• Study Serum Bank (Section 7.9) 
7 . 4 Exploratory Laparotomy 
Patients who have elected to undergo exploratory laparotomy with potential placement of a 
hepatic artery infusion pump will proceed to laparotomy after an observation period of at 
least 7 days following ACN53 treatment, and only if and when they are deemed surgically 
fit (see Section 8.4, Criteria for Post-Treatment Laparotomy) .These patients will have the 
following additional evaluations during laparotomy: 
[682] 
Recombinant DNA Research, Volume 20 
