Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer

Summary

This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or second) platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point.

Timeline

Start

2013-07

Primary completion

2018-03-18

Completion

2018-03-18

Outcome

Mixed primary results

paper Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months PMID 31537908 ↗

paper BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). PMID 31537908 ↗

paper BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%). PMID 31537908 ↗

Publications

• Results Colombo N, Zaccarelli E, Baldoni A, Frezzini S, Scambia G, Palluzzi E, Tognon G, Lissoni AA, Rubino D, Ferrero A, Farina G, Negri E, Pesenti Gritti A, Galli F, Biagioli E, Rulli E, Poli D, Gerardi C, Torri V, Fossati R, D'Incalci M. Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer. Br J Cancer. 2019 Oct;121(9):744-750. doi: 10.1038/s41416-019-0584-5. Epub 2019 Sep 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Carboplatin	Small molecule	4 unknown	—
Subject	Trabectedin	Small molecule	0.8 mg/m2	Intravenous
Subject	Trabectedin	Small molecule	1.1 mg/m2	Intravenous

Indications