Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

Korábbi kezelés

• Other malignant disease 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.
• 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:
  • 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
  • Peripheral vascular disease grade ≥ 3

Más betegség

• Underlying medical disease not adequately treated (diabetes, cardiac disease).
• Uncontrolled hypertension (BP > 150/100 despite antihypertensive treatment).
• Allergy to active substance or any of the auxiliary agents
• Bleeding tumor

Egyéb

• Intestinal infiltration or infiltration in major blood vessels at the discretion of the treating physician.
• 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.

• 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):
  • WBC ≥ 3.0 x 10\^9/l or neutrophils (ANC) ≥ 1.5 x 10\^9/l
  • Platelet count ≥ 100 x 10\^9/l
  • Hemoglobin ≥ 6 mmol/l
  • Serum bilirubin < 2.0 x ULN
  • Serum transaminase ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 ULN
• Urine dipstick for protein < 2+. If the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents < 1 g.
• Written informed consent