Chemotherapy resistant ovarian cancer with progressive disease. MedDRA version: 17.1 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion 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 * 109/l or neutrophils (ANC) = 1.5 * 10^9/l - Platelet count = 100 * 10^9/l - Hemoglobin = 6 mmol/l - Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer;Secondary Objective: • To investigate quality of life during treatment • To investigate the potential toxicity of the treatment • To investigate progression free and overall survival ;Primary end point(s): • Fraction of patients without progression after six months of treatment;Timepoint(s) of evaluation of this end point: 6 months after first treatment day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Quality of life 2 Safety 3 Progression free survival 4 Overall survival;Timepoint(s) of evaluation of this end point: 1+3 = Every 9 weeks 2 = Every 3 weeks | — |
Countries
Denmark
Contacts
Public ContactKlinisk Forskningsenhed
Vejle Hospital
Outcome results
None listed