Clinical trial NCT02399592: Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
Official title: Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Platinum resistant
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Fraction of patients without progression after six months of treatment
timeFrame: 6 months after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: Department of Oncology, Vejle Hospital
name: Anders Jakobsen, DMSc
role: STUDY_CHAIR
References: