Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer (Toco-Ovar)

Vejle Hospital

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Bevacizumab

Drug: Tocotrinol

Study type

Interventional

Funder types

Other

Identifiers

NCT02399592

Toco-Ovar

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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