Table 2.
Adverse Events (Worst Incidence, Grade > 1) Related to Study Medications
| Adverse Event | Dose Level 1 FOLFOX/Erlotinib 50 mg (n = 3) | Dose Level 2A (FOLFOX/Erlotinib 100 mg (n = 3); and 2B (With Bevacizumab (n = 5)a | Dose Level 3 FOLFOX/Erlotinib 150 mg (n = 3) |
|---|---|---|---|
| General | |||
| Dehydration | – | Grade 3:1 | Grade 2:1; Grade 3:1 |
| Fatigue | Grade 2:1 | Grade 2:3 | – |
| Fever | – | Grade 2:1 | Grade 2:1 |
| Dermatologic | |||
| Alopecia | – | Grade 2:1 | – |
| Dry skin | – | – | – |
| Hand-foot skin reaction | – | Grade 2:1 | Grade 2:1 |
| Maculopapular rash | Grade 2:1 | Grade 2:3 | Grade 2:3b,c |
| Gastrointestinal | |||
| Abdominal pain | Grade 2:1 | Grade 2:2 | Grade 2:1 |
| Anorexia | – | Grade 2:1; Grade 3:1 | – |
| Diarrhea | Grade 2:1; Grade 3:1 | Grade 2:4; Grade 3:2 | Grade 3:3 |
| Mucositis | – | Grade 2:1; Grade 3:1c | – |
| Pneumatosis | Grade 3:1 | – | Grade 3:1 |
| Nausea/vomiting | – | Grade 2:2 | – |
| Laboratory, Chemical | |||
| Alkaline phosphatase elevated | – | – | Grade 2:1; Grade 3:1 |
| ALT elevation | – | Grade 2:1 | Grade 2:1 |
| AST elevation | – | Grade 2:1 | Grade 2:1 |
| Elevated bilirubin | – | Grade 2:1 | Grade 3:1 |
| Laboratory, Hematologic | |||
| Neutropenia | Grade 2:1; Grade 3:1 | Grade 2:2; Grade 3:2; Grade 4:1 | Grade 2:1; Grade 4:1c |
| Hemoglobin | – | Grade 2:1 | Grade 1:2; Grade 3:2 |
| Thrombocytopenia | – | Grade 2:1; Grade 3:1 | – |
| Other | |||
| Thrombosis/embolism | – | Grade 3:1 | – |
a
One patient who did not receive FOLFOX/erlotinib/bevacizumab not included.
b
One patient’s rash did not improve to tolerable within 2 weeks, and thus was graded as a DLT.
c
These adverse events indicate DLT.
Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; DLT = dose-limiting toxicity; FOLFOX = infusional 5-fluorouracil/leucovorin/oxaliplatin