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

Sponsor
Vejle Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02399592
Collaborator
(none)
23
1
1
52
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bevacizumab and Tocotrienol

Drug: Bevacizumab
10 mg/kg q3w

Drug: Tocotrinol
300 mg tid

Outcome Measures

Primary Outcome Measures

  1. Fraction of patients without progression after six months of treatment [6 months after start of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Oncology, Vejle Hospital Vejle Denmark DK-7100

Sponsors and Collaborators

  • Vejle Hospital

Investigators

  • Study Chair: Anders Jakobsen, DMSc, Department of Oncology, Vejle Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT02399592
Other Study ID Numbers:
  • Toco-Ovar
First Posted:
Mar 26, 2015
Last Update Posted:
Nov 30, 2020
Last Verified:
Feb 1, 2020
Keywords provided by Vejle Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2020