Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

NCT04175470 | Completed Phase 2

• 1 other identifier: BeTo-Ovar
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  6 months after enrollment of the last patient

Secondary Outcomes (3)

• Overall survival

  12 months after enrollment of the last patient

• Response rate as measured by RECIST 1.1 or CA-125

  6 months after enrollment of the last patient

• Safety as measured by CTC version 5.0

  Every 9 weeks until progression, up to 3 years

Study Arms (2)

Arm A: Discontinue treatment after first treatment cycle

EXPERIMENTAL

Drug: Bevacizumab; Dietary Supplement: Tocotrienol

Arm B: Continue treatment until progression

EXPERIMENTAL

Drug: Bevacizumab; Dietary Supplement: Tocotrienol

Interventions

Bevacizumab DRUG

10 mg/kg intravenously every three weeks

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

Tocotrienol DIETARY_SUPPLEMENT

Capsules, 300 mg orally three times daily

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Interventions

Bevacizumab; Tocotrienols

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Torben F Hansen, MD, DMSc

  Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 25, 2019
• Study Start: October 29, 2019
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

DK (1)