Table 2.
Treatment-related grade ≥ 2 adverse events
| Dose level | 1 n = 1 |
2 n = 2 |
3 n = 0 |
4 n = 1 |
5 n = 6 |
6 n = 4 |
7 n = 3 |
8 n = 19 |
Total N = 36 |
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Bevacizumab IV q2w (mg/kg) |
2.5 | 5 | 5 | 5 | 7.5 | 7.5 | 7.5 | 10 | ||
|
Cetuximab IV weekly (mg/m2)* |
100, 75 | 100, 75 | 200, 125 | 200, 125 | 200, 125 | 400, 250 | 400, 250 | 400, 250 | ||
|
Erlotinib PO daily (mg) |
50 | 50 | 50 | 100 | 100 | 100 | 150 | 150 | ||
| Rash | ||||||||||
| Grade 2 | 0 | 0 | 0 | 1 | 3 | 2 | 0 | 10 | 16 (44%) | |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4 (11%) | |
| Pruritus | ||||||||||
| Grade 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 2 (6%) | |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 (6%) | |
| Diarrhea | ||||||||||
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 (8%) | |
| Fatigue | ||||||||||
| Grade 2 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 (6%) | |
| Hand-foot syndrome | ||||||||||
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 (6%) | |
| Hypomagnesemia | ||||||||||
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 (6%) | |
| Grade 3–4 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 4 (11%) | |
| Nausea/vomiting | ||||||||||
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (3%) | |
| Mucositis | ||||||||||
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (3%) | |
| Anorexia | ||||||||||
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 (6%) | |
| Hypertension | ||||||||||
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (3%) | |
| Bleeding | ||||||||||
| Grade 3 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 3 (8%) | |
| Elevated AST/ALT | ||||||||||
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (3%) | |
| Anemia | ||||||||||
| Grade 3 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 (3%) | |
| Transvaginal fistula | ||||||||||
| Grade 4 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 (6%) | |
* Cetuximab dose shown as loading dose and maintenance dose