Ovarian Cancer
Conditions
Keywords
Platinum resistant
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.
Interventions
DRUGBevacizumab
10 mg/kg q3w
DRUGTocotrinol
300 mg tid
Sponsors
Vejle Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fraction of patients without progression after six months of treatment | 6 months after start of treatment |
Countries
Denmark
Outcome results
None listed