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