Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Bevacizumab; Drug: Tocotrinol

• Registration Number: NCT02399592
• Lead Sponsor: Vejle Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab and Tocotrienol	Tocotrinol	-
Bevacizumab and Tocotrienol	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Fraction of patients without progression after six months of treatment	6 months after start of treatment

Trial Locations

Locations (1)

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark