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Phase 2 paclitaxel, carboplatin and bortezomib trial stopped accrual early due to toxicity, limited benefit
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Survival in metastatic melanoma has not previously been strongly affected by chemotherapy, and a new phase 2 trial of paclitaxel, carboplatin and bortezomib was similarly ineffective. The lack of efficacy and high toxicity led to an early halt to accrual in the trial.
“The limited effectiveness of current therapeutic approaches in patients with metastatic melanoma underscores the importance of developing novel agents,” the researchers wrote. Recent preclinical studies have indicated a potential benefit with bortezomib when combined with other agents.
In the phase 2 study, 17 patients were enrolled and received a median of four cycles of the combination therapy. Patients received 1.3 mg/m2 IV bortezomib (Velcade, Millenium) on days 1, 4 and 8; paclitaxel was administered at a dose of 175 mg/m2 on day 2; and carboplatin at an area under the concentration of six also on day 2 of the 21-day cycle.
There were two confirmed partial responses; both patients had prior chemotherapy. Four other patients had disease that remained stable for at least 12 weeks.
The median PFS was 3.2 months and the median OS time was 7 months.
Toxicity was significant, with 71% of patients experiencing severe neutropenia; 41% had severe leucopenia, and 29% had severe thrombocytopenia.
“Bortezomib as a single agent or in combination with paclitaxel and carboplatin lacks sufficient clinical activity in patients with metastatic melanoma to warrant further investigation,” the researchers wrote. They noted that the latter two agents combined with sorafenib (Nexavar, Bayer) is also currently being tested.
For more information:
- Croghan GA. Cancer. 2010;doi:10.1002/cncr.25191.