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)
was defined as a dose-limiting toxicity
Abbreviations: N, number of patients