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. 2016 Feb 24;7(17):23227–23238. doi: 10.18632/oncotarget.7594

Table 2. Dose-Escalation Schedule (28-day cycle), Grade 3/4 Toxicities* and Response.

Dose Level N Temsirolimus IV on Days 1, 8, 15, 22 Bevacizumab IV on Days 1, 15 Cetuximab IV on Days 1, 8, 15, 22 SD≥6 months or PR /Total treated Grade (G) 3/4 Toxicity (N)*
1 3 5 mg 5 mg/kg 100/75 mg/m2 1/3 G3/4 Neutropenia (1)
2 16 5 mg 10 mg/kg 100/75 mg/m2 5/16 G3 Hypophosphatemia (1)
G3 Elevated Aspartate Aminotransferase (1)Δ
G3 Hyperglycemia (3)
G3 Hypokalemia (1)
G3 Anemia (1)
G3 Hyperkalemia (1)
G3 Infusion reaction (1)Δ
G3 Vomiting (1)
G4 Stomach leak/perforation (1)Δ
3 2 12.5 mg 2.5 mg/kg 100/75 mg/m2 0/2 G3 Headache (1)Δ
G3 Hypophosphatemia (2)
G3 Mucositis (1)Δ
G3 Fatigue (1)Δ
*

Adverse events deemed at least possibly related to treatment were graded based on the Common Terminology Criteria for Adverse Events, version 3.0 (CTCAEv3.0)

Δ

was defined as a dose-limiting toxicity

Abbreviations: N, number of patients