Overview

Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

Status:
Completed
Trial end date:
2019-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vejle Hospital
Treatments:
Bevacizumab
Tocopherols
Tocotrienols
Vitamin E
Criteria
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