Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.

Official Title
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Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Tocotrinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Prior treatment with at least two different cytostatic regimens including platinum. Progression on previous treatment. Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria. Age ≥ 18 years. Performance stage 0-2. Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): WBC ≥ 3.0 * 10^9/l or neutrophils (ANC) ≥ 1.5 * 109/l Platelet count ≥ 100 * 10^9/l Hemoglobin ≥ 6 mmol/l Serum bilirubin < 2.0 * ULN Serum transaminase ≤ 2.5 * ULN Serum creatinine ≤ 1.5 ULN Urine dipstick for protein <2+. If the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents < 1 g. Written informed consent. Exclusion Criteria: Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence. Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation. Underlying medical disease not adequately treated (diabetes, cardiac disease). Uncontrolled hypertension (BT >150/100 despite antihypertensive treatment). Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab. Non-healing wounds or fractures. Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment. Clinically 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 Periferal vascular disease grade ≥ 3 Allergy to the 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab and Tocotrienol<br> | Drug: Bevacizumab<br>* 10 mg/kg q3w<br>Drug: Tocotrinol<br>* 300 mg tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of patients without progression after six months of treatment |  | 6 months after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platinum resistant