Tocotrienol as a nutritional supplement in patients with advanced ovarian cancer
- Conditions
- Chemotherapy resistant ovarian cancer with progressive disease.MedDRA version: 17.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004858-18-DK
- Lead Sponsor
- Vejle Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 23
•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 * 109/l or neutrophils (ANC) = 1.5 * 10^9/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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer;Secondary Objective: •To investigate quality of life during treatment<br>•To investigate the potential toxicity of the treatment<br>•To investigate progression free and overall survival<br>;Primary end point(s): •Fraction of patients without progression after six months of treatment;Timepoint(s) of evaluation of this end point: 6 months after first treatment day
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1Quality of life<br>2Safety<br>3Progression free survival<br>4Overall survival;Timepoint(s) of evaluation of this end point: 1+3 = Every 9 weeks<br>2 = Every 3 weeks