NCT04175470

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A recent study at the Department of Oncology, Vejle Hospital (NCT02399592), investigated bevacizumab and tocotrienol in ovarian cancer patients and concurrently monitored the level of methylated HOXA9 circulating tumor DNA (HOXA9 meth-ctDNA) in the blood. The rate of disease control was 70% with better results than other studies using bevacizumab alone. The toxicity was very low and attributed to bevacizumab only. When the study results were worked up they showed that patients with a significant increase of HOXA9 meth-ctDNA after the first cycle of treatment did not benefit from the treatment whereas those with stable or decreasing HOXA9 meth-ctDNA did. Therefore, in the current study patients with a high increase of HOXA9 meth-ctDNA after the first treatment cycle will discontinue treatment, as it is then considered ineffective. The remaining patients may achieve prolonged survival as predicted by their level of HOXA9 meth-ctDNA.

Conditions

• Ovarian Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Bevacizumab	10 mg/kg intravenously every three weeks
DIETARY_SUPPLEMENT	Tocotrienol	Capsules, 300 mg orally three times daily

Timeline

• Start date: 2019-10-29
• Primary completion: 2024-07-30
• Completion: 2024-12-31
• First posted: 2019-11-25
• Last updated: 2025-01-03

Locations

1 site across 1 country: Denmark