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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
10 mg/kg intravenously every three weeks
Capsules, 300 mg orally three times daily
Department of Oncology, Vejle Hospital
Vejle, Denmark
Progression free survival
Time frame: 6 months after enrollment of the last patient
Overall survival
Time frame: 12 months after enrollment of the last patient
Response rate as measured by RECIST 1.1 or CA-125
Time frame: 6 months after enrollment of the last patient
Safety as measured by CTC version 5.0
CTC = National Cancer Institute's Common Toxicity Criteria (NCI-CTC)
Time frame: Every 9 weeks until progression, up to 3 years
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