Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of epithelial ovarian carcinoma or fallopian tube carcinoma or primary peritoneal carcinoma
First disease recurrence >6 months after first-line platinum-based chemotherapy
Patients with measurable or non-measurable disease (RECIST v1.1) or CA 125 assessable disease (GCIG criteria) or histological proven diagnosis of relapse
In case of cytoreductive surgery for recurrence, patients must be able to commence cytotoxic chemo-therapy within 8 weeks after cytoreductive surgery
ECOG PS 0-2
Absolute Neutrophil Count >= 1.5 x 10^9/L; Platelets >= 100 x 10^9/L; Hemoglobin >= 9.5 g/dL
Patients not receiving anticoagulant medication who have an International Normalized Ratio <= 1.5 and an Activated ProThrombin Time <= 1.5 x ULN
Serum bilirubin <= 2 x ULN; Serum transaminases <= 2.5 x ULN (<= 5 x ULN in the presence of liver metastasis)
Serum creatinine < 1.6 mg/dL or creatinine clearance >= 40 mL/min; Glomerular filtration rate > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula); Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24 hour urine collection must demonstrate <= 1 g of protein in 24 hours
Normal blood pressure or adequately treated and controlled hypertension (either systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg)

Exclusion Criteria:

Ovarian tumors of low malignant potential
Malignancies other than ovarian cancer within 5 years prior to randomization
Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period
Any previous radiotherapy to the abdomen or pelvis
Known hypersensitivity to used chemotherapeutic agents in this trial and bevacizumab and its excipients, chinese hamster ovary cell products or other recombinant human or humanised antibodies
Current or recent chronic use of aspirin > 325 mg/day
Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of Bevacizumab
History of VEGF therapy related abdominal fistula or gastrointestinal perforation
Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Previous Cerebro-Vascular Accident , Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage
Prior history of hypertensive crisis or hypertensive encephalopathy
Clinically significant disease, including: myocardial infarction or unstable angina within ≤ 6 months of randomization; New York Heart Association (NYHA) >= grade 2 Congestive Heart Failure; poorly controlled cardiac arrhythmia despite medication; peripheral vascular disease grade >= 3
LVEF defined by ECHO/MUGA below the institutional lower limit of normal
Significant traumatic injury during 4 weeks prior to randomization
Current brain metastases or spinal cord compression
History or evidence upon neurological examination of central nervous system disease
Non-healing wound, active ulcer or bone fracture
History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic coagulation)
Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the duration of the trial and at least 6 months afterwards
Pregnant or lactating women
Requirement of therapeutic anticoagulation using marcumar, warfarin or PTT-prolonging heparin