Table 1. Dose-escalation scheme: treatment cohorts with number of patients treated and courses given.
Trial arms |
Arm 1: CA4P/Carboplatin
|
Arm 2: CA4P/Paclitaxel
|
Arm 3: CA4P/Carboplatin/Paclitaxel
|
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cohort | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 |
CA4P dose (mg m−2) | 36 | 45 | 45 | 60 | 54 | 27 | 27 | 36 | 45 | 54 | 54 | 63 | 72 |
Carboplatin AUC | 4 | 4 | 5 | 5 | 5 | — | — | — | — | — | 5 | 5 | 5 |
Paclitaxel dose (mg m−2) | — | — | — | — | — | 135 | 175 | 175 | 175 | 175 | 175 | 175 | 175 |
Number of patients | 3 | 3 | 3 | 1 | 5 | 4 | 3 | 3 | 4 | 5 | 4 | 6 | 2 |
Total number of cycles | 14 | 8 | 11 | 1 | 21 | 16 | 11 | 10 | 11 | 20 | 23 | 27 | 6 |
Abbreviations: AUC=area under the concentration curve; CA4P=combretastatin A4 phosphate.