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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab and Tocotrienol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 10 mg/kg q3w |
| |
| Tocotrinol |
| Measure | Description | Time Frame |
|---|---|---|
| Fraction of patients without progression after six months of treatment | 6 months after start of treatment |
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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):
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Anders Jakobsen, DMSc | Department of Oncology, Vejle Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Vejle Hospital | Vejle | DK-7100 | Denmark |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
300 mg tid |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |