Ovarian cancer MedDRA version: 20.0 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Bevacizumab
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Other descriptive name: BEVACIZUMAB
Concentrat
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed epithelial ovarian cancer, primary fallopian or primary peritoneal cancer. • Platinum resistant epithelial ovarian cancer treated with at least two different previous chemotherapeutic regimens • Progression on previous treatment. Previous treatment with bevacizumab is allowed. • Measurable disease by the RECIST 1.1 criteria or evaluable by the GCIG CA-125 criteria. • Age = 18 years. • Performance status 0-2. • Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): o WBC = 3.0 x 10^9/l or neutrophils (ANC) = 1.5 x 10^9/l o Platelet count = 100 x 10^9/l o Hemoglobin = 6 mmol/l o Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Other malignant diseases within 3 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin. • Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation. • Intestinal infiltration or infiltration in major blood vessels at the discretion of the treating physician. • Underlying medical disease not adequately treated (diabetes, cardiac disease). • Uncontrolled hypertension (BP > 150/100 despite antihypertensive treatment). • Surgery including open biopsy, within 4 weeks prior to first dose of bevacizumab. • Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months before start of treatment. • Clinical significant cardiovascular disease, including: o Myocardial infarction or unstable angina within 6 months before start of treatment o New York Heart Association (NYHA) class = 2 o Poorly controlled cardiac arrhythmia despite medication o Peripheral vascular disease grade = 3 • Allergy to 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 bevacizumab and tocotrienol based on the level of methylated circulating tumor specific HOXA9 DNA (HOXA9 meth-ctDNA) after the first treatment cycle assessed by progression free survival;Secondary Objective: • To investigate overall survival • To investigate the response rate • To investigate potential toxicity to treatment ;Primary end point(s): Progression free survival after the first cycle of treatment;Timepoint(s) of evaluation of this end point: Every 9 weeks until progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Overall survival 2 Response rate 3 Safety ;Timepoint(s) of evaluation of this end point: 1. One year after enrolment of the last patient 2. Every 9 weeks until progression 3. Every three weeks until progression | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit
Vejle Hospital
Outcome results
None listed