Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

NCT ID: NCT04175470

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-29
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Discontinue treatment after first treatment cycle

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

10 mg/kg intravenously every three weeks

Tocotrienol

Intervention Type: DIETARY_SUPPLEMENT

Capsules, 300 mg orally three times daily

Arm B: Continue treatment until progression

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

10 mg/kg intravenously every three weeks

Tocotrienol

Intervention Type: DIETARY_SUPPLEMENT

Capsules, 300 mg orally three times daily

Interventions

Bevacizumab

10 mg/kg intravenously every three weeks

Intervention Type: DRUG

Tocotrienol

Capsules, 300 mg orally three times daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torben F Hansen, MD, DMSc

Role: STUDY_CHAIR

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

Locations

Department of Oncology, Vejle Hospital

Vejle, , Denmark

Countries

Denmark

Other Identifiers

BeTo-Ovar

Identifier Type: -

Identifier Source: org_study_id