Table 4. Common Toxicities during High-Dose TIC by Cohort in Phase I.
| Cohort 1 (n=3) | Cohort 2 (n=3) | Cohort 3 (n=3) | Cohort 4 (n=3) | Cohort 5 (n=6) | Total (n=18) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Toxicity | G3 | G4 | G3 | G4 | G3 | G4 | G3 | G4 | G3 | G4 | G3/4 |
| Leukocytopenia | 3 | 3 | 3 | 3 | 6 | 18 | |||||
| Lymphopenia | 2 | 1 | 1 | 2 | 3 | 1 | 2 | 1 | 5 | 18 | |
| Neutropenia | 3 | 3 | 3 | 3 | 6 | 18 | |||||
| Thrombocytopenia | 3 | 3 | 3 | 3 | 6 | 18 | |||||
| Anemia | 3 | 2 | 1 | 2 | 2 | 1 | 4 | 2 | 17 | ||
| Hypophosphatemia | 1 | 3 | 1 | 1 | 2 | 1 | 3 | 1 | 13 | ||
| Hypokalemia | 2 | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 1 | 13 | |
| Elevated ALT | 2 | 1 | 1 | 5 | 9 | ||||||
| Febrile neutropenia | 2 | 2 | 1 | 2 | 7 | ||||||
| Hyperglycemia | 1 | 1 | 1 | 1 | 3 | 7 | |||||
| Hyponatremia | 1 | 1 | 2 | 3 | 7 | ||||||
| Elevated Lipase | 1 | 2 | 3 | ||||||||
| Elevated AST | 2 | 2 | |||||||||
| Dyspnea | 1 | 1 | 2 | ||||||||
| Fatigue | 1 | 1 | 2 | ||||||||
| Hypotension | 1 | 1 | 2 | ||||||||
| Elevated Creatinine | 1 | 1 | 2 | ||||||||
Abbreviations: TIC, paclitaxel, ifosfamide, and carboplatin; G = grade; ALT = alanine aminotransferase; AST, aspartate aminotransferase