Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

Vejle Hospital1 site in 1 country23 target enrollmentMarch 2015

ConditionsOvarian Cancer

InterventionsBevacizumab Tocotrinol

DrugsBevacizumab Tocotrinol

Overview

Phase: Phase 2
Intervention: Bevacizumab
Conditions: Ovarian Cancer
Sponsor: Vejle Hospital
Enrollment: 23
Locations: 1
Primary Endpoint: Fraction of patients without progression after six months of treatment
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

July 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Vejle Hospital

Responsible Party

Sponsor

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-
•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

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