Table 5.
All adverse events at the maximal tolerated dose (MTD) dose level III(b) (N = 6 patients, 11 cycles of treatment
| Toxicity | Toxicity grade |
||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| Albumin | 1 | 1 | |||
| Anorexia | 3,2 | 3 | 1a | ||
| Anxiety | 1 | ||||
| Bilirubin | 1 | ||||
| Bladder spasm | 1 | ||||
| Bone pain | 1 | ||||
| Constipation | 1 | ||||
| Cough | 1,2 | ||||
| Creatinine | 1a | ||||
| Dehydration | 1a | ||||
| Diarrhea | 4,1 | 1 | |||
| Dizziness/vertigo | 2 | ||||
| Dyspnea | 1 | 1,1b | 1a | ||
| Edema | 1a | ||||
| Fatigue | 1,2 | ||||
| Fever/infection | 1,3 | 3 | |||
| Headache | 1 | 1 | |||
| Hyperglycemia | 3 | 6 | |||
| Hemoglobin | 1 | ||||
| Hot flash | 1 | ||||
| Hypoglycemia | 1 | 2 | |||
| Hyperkalemia | 1 | ||||
| Hypoglycemia | 1 | ||||
| Hypomagnesemia | 1 | ||||
| Hyponatremia | 1 | ||||
| Hypotension | 1 | ||||
| Hypoxia | 1b | 1a | |||
| Lymphopenia | 1 | ||||
| Nausea | 9 | 4 | |||
| Pleural effusion | 1 | ||||
| Pneumothorax | 1b | ||||
| PT/PTT | 4 | 1 | |||
| SGOT/SGPT | 2 | ||||
| SVT | 1a | ||||
| Sweating | 1 | ||||
| Taste disturbance | 3 | ||||
| Transfusion, RBC | 3 | ||||
| Tumor flare | 2 | ||||
| Urinary frequency | 1 | ||||
| Vertigo | 1 | ||||
| Vision change | 1 | ||||
| Vomiting | 7,2 | 3 | |||
| Weight loss | 2 | ||||
Relation to drug: italics: unrelated or unlikely; bold: possible, probable or likely
a
One patient with sarcoma and pulmonary metastases experienced grade 3 anorexia, increased creatine, dehydration, edema, grade 4 hypotension with dyspnea and hypoxia with radiographic evidence of progression of disease
b
One patient without widespread metastases to liver, lung and pleural effusions also felt to have disease progression