Day 0 Day 10 Day 28  
Weight Changes from Day 0        
5-7.5% weight loss - 13.6% (3/22) 0% (0/21)  
7.5-10% - 0% (0/22) 11.1% (2/18)  
> 10% - 0% (0/22) 5.6% (1/18)  
total - 13.6% (3/22) 16.7% (3/18) -
Fever (≥ 103°F) 0% (0/20) 5.6% (1/18) 5.6% (1/18) p = 0.26
GI Toxicities        
Anorexia 17.4% (4/23) 27.3 % (6/22) 11.1% (2/18) p = 0.30
Grade 1-2 3/23 4/22 0/18  
Grade 3-4 1/23 2/22 2/18  
Vomiting 0% (0/23) 0% (0/22) 16.7% (3/18) p = 0.07
Grade 1-2 0/23 0/22 3/18  
Grade 3-4 0/23 0/22 0/18  
Diarrhea 8.7% (2/23) 4.5% (1/22) 11.1% (2/18) p = 0.64
Grade 1-2 2/23 1/22 2/18  
Grade 3-4 0/23 0/22 0/18  
Hematologic Toxicities (all grade ≤ 2)        
Neutropenia 0% (0/23) 9.1% (2/22) 11.8% (2/17) p = 0.07
Thrombocytopenia 0% (0/23) 4.5% (1/22) 0% (0/17) p = 0.31
Lymphopenia 0% (0/23) 13.6% (3/22) 11.8% (2/17) p = 0.07
Renal Toxicity (Creatinine) (all grade ≤ 2) 4.3% (1/23) 4.5% (1/22) 0% (0/17) p = 1.0
Hepatic Toxicity (ALT) 17.4% (4/23) 18.2% (4/22) 17.6% (3/17) p = 0.71
Grade 1-2 3/23 3/22 2/17  
Grade 3-4 1/23 1/22 1/17  
Table 2: Toxicities.