Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer (Toco-Ovar)
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Bevacizumab
Tocotrinol
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Platinum resistant
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
Sites / Locations
- Department of Oncology, Vejle Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab and Tocotrienol
Arm Description
Outcomes
Primary Outcome Measures
Fraction of patients without progression after six months of treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02399592
Brief Title
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
Acronym
Toco-Ovar
Official Title
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Platinum resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab and Tocotrienol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
10 mg/kg q3w
Intervention Type
Drug
Intervention Name(s)
Tocotrinol
Intervention Description
300 mg tid
Primary Outcome Measure Information:
Title
Fraction of patients without progression after six months of treatment
Time Frame
6 months after start of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jakobsen, DMSc
Organizational Affiliation
Department of Oncology, Vejle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
We'll reach out to this number within 24 hrs