Table 1.

Patient Characteristics (N=16)

Characteristic	No. (%)
Sex
Male	10 (62.5)
Female	6 (37.5)
Median Age, years	14.7
Range	5.3-20.7
Diagnosis
Osteosarcoma	5 (31.25)
Neuroblastoma	3 (18.75)
Sarcoma	3 (18.75)
Carcinoma	1 (6.25)
Germ Cell Tumor	1 (6.25)
Hepatocellular Carcinoma/Transitional Liver Cell Tumor	1 (6.25)
Liposarcoma	1 (6.25)
Small Round Cell Tumor	1 (6.25)
Irinotecan Dose Level
Level 1 - 5 mg/m2/day (daily × 5) × 2	1 (6.25)
Level 2 - 10 mg/m2/day (daily × 5) × 2	3 (18.75)
Level 3 - 14 mg/m2/day (daily × 5) × 2	2 (12.5)
Level 4 - 20 mg/m2/day (daily × 5) × 2	4 (25)
Level 5 - 25 mg/m2/day (daily × 5) × 2	2 (12.5)
Level 6 - 30 mg/m2/day (daily × 5) × 2	2 (12.5)
Level 7 - 40 mg/m2/day (daily × 5) × 2	2 (12.5)
Gefitinib Dose - Fixed at 150 mg/m2/day daily × 12 days
Number of Assessable Courses	50
Median No. of courses per patient	2
Range	1-20