Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

NCT ID: NCT02399592

Last Updated: 2020-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-07-31

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.

Conditions

Ovarian Cancer

Keywords

Platinum resistant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab and Tocotrienol

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

10 mg/kg q3w

Tocotrinol

Intervention Type: DRUG

300 mg tid

Interventions

Bevacizumab

10 mg/kg q3w

Intervention Type: DRUG

Tocotrinol

300 mg tid

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Jakobsen, DMSc

Role: STUDY_CHAIR

Department of Oncology, Vejle Hospital

Locations

Department of Oncology, Vejle Hospital

Vejle, , Denmark

Countries

Denmark

Other Identifiers

Toco-Ovar

Identifier Type: -

Identifier Source: org_study_id