Table 1. . Phase II and III paclitaxel trials in melanoma.
| Study (author) | Treatment arms | Number per arm | ORR (CR/PR) | CRR (CR/PR/SD) | Median PFS/TTP | Median OS | Ref. |
|---|---|---|---|---|---|---|---|
| Phase II P single agent (Walker et al.) | P 80 mg/m2, 3 weeks on, 1 week off | 27 | 0% | 30% | PFS: 1.8 months | 7.6 months | [26] |
| Phase II P single agent (Einzig et al.) | P 250 mg/m2 every 21 days | 34 | 14% | – | – | – | [27] |
| Randomized Phase II P vs P plus carboplatin (Zimpfer-Rechner et al.)† | P 80 mg/m2 every week for 6 weeks, repeated every 8 weeks | 18 | 0% | 28% | TTP: 54 days | 218 days | [28] |
| P 80 mg/m2 and carboplatin 200 mg/m2 every week for 6 weeks, repeated every 8 weeks | 16 | 0% | 19% | TTP: 57 days | 209 days | ||
| Phase II, randomized, double-blind trial of P ± elesclomol (O’Day et al.) | P 80 mg/m2, 3 weeks on, 1 week off | 28 | 3.6% | 39.3% | PFS: 1.8 months (95% CI: 1.6–3.4) | 7.8 months‡ | [29] |
| P 80 mg/m2 plus eclesclomol 213 mg/m2, 3 weeks on, 1 week off | 53 | 15.1% | 62.3% | PFS: 3.7 months (95% CI: 2.5–5.5) | 11.9 months | ||
| Phase III SYMMETRY study; randomized, double-blind trial of P ± elesclomol (O’Day et al.)§ | P 80 mg/m2, 3 weeks on, 1 week off | 326 | 4% | 18% | PFS: 1.9 months | 11.4 months | [25] |
| P 80 mg/m2 plus eclesclomol 213 mg/m2, 3 weeks on, 1 week off | 325 | 7% | 22% | PFS: 3.4 months | 10.6 months | ||
†Trial stopped early due to ORR of <10%.
‡Crossover allowed.
§Trial closed early due to the finding of an imbalance in total deaths favoring paclitaxel, predominantly in patients with high lactate dehydrogenase levels.
CR: Complete response; CRR: Clinical response rate; ORR: Overall response rate; OS: Overall survival; P: Weekly paclitaxel; PFS: Progression-free survival; PR: Partial response; SD: Stable disease; TTP: Time to progression.