Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

Sponsor
Vejle Hospital
Study ID
NCT04175470
Phase
PHASE2
Status
Completed

Conditions

  • Ovarian Cancer Recurrent

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    10 mg/kg intravenously every three weeks
  • Tocotrienol — DIETARY_SUPPLEMENT
    Capsules, 300 mg orally three times daily

Study Details

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.

Key Dates

First listed
Nov 25, 2019
Start date
Oct 29, 2019
Status verified
Jan 2025
Primary completion
Jul 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Discontinue treatment after first treatment cycle
  • Experimental: Arm B: Continue treatment until progression

Primary Outcome Measure

Progression free survival [ Time Frame: 6 months after enrollment of the last patient ]

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