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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02399592
Recruitment Status : Active, not recruiting
First Posted : March 26, 2015
Last Update Posted : September 25, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Bevacizumab Drug: Tocotrinol Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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 : March 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Bevacizumab and Tocotrienol Drug: Bevacizumab
10 mg/kg q3w

Drug: Tocotrinol
300 mg tid

Primary Outcome Measures :
  1. Fraction of patients without progression after six months of treatment [ Time Frame: 6 months after start of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02399592

Department of Oncology, Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
Study Chair: Anders Jakobsen, DMSc Department of Oncology, Vejle Hospital

Responsible Party: Vejle Hospital Identifier: NCT02399592     History of Changes
Other Study ID Numbers: Toco-Ovar
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Keywords provided by Vejle Hospital:
Platinum resistant

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Vitamin E
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents