Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

January 2, 2025 updated by: Vejle Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, 7100
        • Department of Oncology, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed epithelial ovarian cancer, primary fallopian or primary peritoneal cancer.
  • Platinum resistant epithelial ovarian cancer treated with at least two different previous chemotherapeutic regimens
  • Progression on previous treatment. Previous treatment with bevacizumab is allowed.
  • Measurable disease by the RECIST 1.1 criteria or evaluable by the GCIG CA-125 criteria.
  • Age ≥ 18 years.
  • Performance status 0-2.

  • Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

    • WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l
    • Platelet count ≥ 100 x 10^9/l
    • Hemoglobin ≥ 6 mmol/l
    • Serum bilirubin < 2.0 x ULN
    • Serum transaminase ≤ 2.5 x ULN
    • Serum creatinine ≤ 1.5 ULN
  • Urine dipstick for protein < 2+. If the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents < 1 g.
  • Written informed consent

Exclusion Criteria:

  • Other malignant disease within 3 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin.
  • Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
  • Intestinal infiltration or infiltration in major blood vessels at the discretion of the treating physician.
  • Underlying medical disease not adequately treated (diabetes, cardiac disease).
  • Uncontrolled hypertension (BP > 150/100 despite antihypertensive treatment).
  • Surgery including open biopsy, within 4 weeks prior to first dose of bevacizumab.
  • Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months before start of treatment.

  • Clinical significant cardiovascular disease, including:

    • Myocardial infarction or unstable angina within 6 months before start of treatment
    • New York Heart Association (NYHA) class ≥ 2
    • Poorly controlled cardiac arrhythmia despite medication
    • Peripheral vascular disease grade ≥ 3
  • Allergy to active substance or any of the auxiliary agents
  • Bleeding tumor
  • Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
  • Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Discontinue treatment after first treatment cycle
Drug: Bevacizumab
10 mg/kg intravenously every three weeks
Dietary supplement: Tocotrienol
Capsules, 300 mg orally three times daily
Experimental: Arm B: Continue treatment until progression
Drug: Bevacizumab
10 mg/kg intravenously every three weeks
Dietary supplement: Tocotrienol
Capsules, 300 mg orally three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 6 months after enrollment of the last patient
6 months after enrollment of the last patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 12 months after enrollment of the last patient
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
6 months after enrollment of the last patient
Safety as measured by CTC version 5.0
Time Frame: Every 9 weeks until progression, up to 3 years
CTC = National Cancer Institute's Common Toxicity Criteria (NCI-CTC)
Every 9 weeks until progression, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Chair: Torben F Hansen, MD, DMSc, Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2019

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeTo-Ovar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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