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A phase II, randomized, controlled, double-blinded trial of weekly elesclomol plus paclitaxel versus paclitaxel alone for stage IV metastatic melanoma
Journal of Clinical Oncology, 10/19/09

O'Day S et al. – E + P resulted in a statistically significant doubling of median PFS, with an acceptable toxicity profile and encouraging OS. A multinational, phase III trial (SYMMETRY) of E + P compared with paclitaxel alone in metastatic melanoma has closed.

Methods

Randomly assigned patients with metastatic melanoma, measurable disease, and one or fewer prior chemotherapy regimens to elesclomol 213 mg/m2 plus paclitaxel 80 mg/m2 (E + P) or to paclitaxel 80 mg/m2 alone at a 2:1 ratio
Regimens were given as 1-hour intravenous infusion weekly, during 3 of every 4 weeks until disease progression per Response Evaluation Criteria in Solid Tumors or death occurred
Patients who experienced progression were unblended, and patients on paclitaxel alone permitted to cross over to E + P
Primary efficacy end point progression-free survival (PFS)
Secondary end points response rate (RR), toxicity, and overall survival

Results

At 21 US sites, 53 patients randomly assigned to E + P, and 28 patients randomly assigned to paclitaxel
Addition of elesclomol to paclitaxel yielded doubling of median PFS (112 v 56 days) and 41.7% risk reduction for disease progression/death
Respective RRs for E + P and paclitaxel groups were 15% and 3%; median OS was 11.9 v 7.8 months
Of patients on paclitaxel alone, 19 [68%] of 28 crossed over to E + P after progression
Weekly E + P well tolerated