Toco-Ovar: Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Bevacizumab and Tocotrienol
|
Drug: Bevacizumab
10 mg/kg q3w
Drug: Tocotrinol
300 mg tid
|
Outcome Measures
Primary Outcome Measures
- Fraction of patients without progression after six months of treatment [6 months after start of treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
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Prior treatment with at least two different cytostatic regimens including platinum.
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Progression on previous treatment.
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Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.
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Age ≥ 18 years.
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Performance stage 0-2.
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Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
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WBC ≥ 3.0 * 10^9/l or neutrophils (ANC) ≥ 1.5 * 109/l
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Platelet count ≥ 100 * 10^9/l
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Hemoglobin ≥ 6 mmol/l
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Serum bilirubin < 2.0 * ULN
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Serum transaminase ≤ 2.5 * ULN
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Serum creatinine ≤ 1.5 ULN
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Urine dipstick for protein <2+. If the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents < 1 g.
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Written informed consent.
Exclusion Criteria:
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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.
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Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
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Underlying medical disease not adequately treated (diabetes, cardiac disease).
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Uncontrolled hypertension (BT >150/100 despite antihypertensive treatment).
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Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.
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Non-healing wounds or fractures.
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Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment.
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Clinically significant cardiovascular disease, including:
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Myocardial infarction or unstable angina within 6 months before start of treatment
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New York heart Association (NYHA) class ≥ 2
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Poorly controlled cardiac arrhythmia despite medication
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Periferal vascular disease grade ≥ 3
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Allergy to the active substance or any of the auxiliary agents
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Bleeding tumor
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Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
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Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Oncology, Vejle Hospital | Vejle | Denmark | DK-7100 |
Sponsors and Collaborators
- Vejle Hospital
Investigators
- Study Chair: Anders Jakobsen, DMSc, Department of Oncology, Vejle Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Toco-Ovar