Table 1: Study Drug Schedules and Dose Levels and for Cilengitide and Paclitaxel.
Study drug dosing, route of administration, schedule, and retreatment interval.
Agent | Dose | Route | Schedule | Retreatment |
---|---|---|---|---|
Cilengitide | As assigned by Randomization Center | IV over 1 hour |
Levels −4, −3, −2, −1, 1*: Days 1, 8 and 15 |
Every 21 days +/− 3 days |
Level 2: Days 1, 2, 8, 9, 15, 16 | ||||
Paclitaxel | As assigned by Randomization Center | IV over 1 hour | Days 1, 8 and 15 | Every 21 days +/− 3 days |
Dose Level | Cilengitide (mg) | Paclitaxel (mg/m2) | |
---|---|---|---|
Dose | Frequency | ||
−4 | 1500 | Once weekly | 60 |
−3 | 2000 | Once weekly | 60 |
−2 | 2000 | Once weekly | 70 |
−1 | 2000 | Once weekly | 80 |
1* | 2000 | Once weekly | 90 |
2 | 2000 | Twice weekly | 90 |
Starting Dose Level