Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

NCT02399592 | Completed Phase 2 DMC

• 1 other identifier: Toco-Ovar
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Fraction of patients without progression after six months of treatment

  6 months after start of treatment

Study Arms (1)

Bevacizumab and Tocotrienol

EXPERIMENTAL

Drug: Bevacizumab; Drug: Tocotrinol

Interventions

Bevacizumab DRUG

10 mg/kg q3w

Bevacizumab and Tocotrienol

Tocotrinol DRUG

300 mg tid

Bevacizumab and Tocotrienol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, DK-7100, Denmark

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anders Jakobsen, DMSc

  Department of Oncology, Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 30, 2020

Record last verified: 2020-02

Locations

DK (1)