Bevacizumab and Carboplatin for Patients With Ovarian Cancer

Inclusion criteria

• Histologically verified epithelial ovarian cancer, primary tubae- or primary peritoneal cancer (Stage I-IV)
• Carboplatin resistant ovarian cancer previously treated with a maximum of three different cytostatic regimens (single substance or in combination).
• Age ≥ 18 years.
• Performance status 0-2.
• Measurable disease according to CA125 GCIG criteria (Gynaecologic Cancer Intergroup) or RECIST (Response Evaluation Criteria in Solid Tumors) (See appendix I+II)
• Adequate bonemarrow, liver and kidney function and coagulation parameters (within seven days of start of treatment).
• ANC ≥ 1.5*109
• Thrombocytes ≥ 100*10^9/L
• Haemoglobin (Hb) ≥ 6 mmol/l
• Se-bilirubin (BR) ≤ 1.5*ULN (Upper Limit of Normal)
• Se-transaminase ≤ 2.5*ULN
• Se-creatinin ≤ 1.5*ULN
• Urin stix for protein <2+ (If stix shows protein ≥2+ urin must be measured 24 hours where the protein content must be under 1 g.)
• INR ≤1.5
• APTT ≤ 1.5*ULN
• Signed informed consent form.

Exclusion criteria

• Patients who have received other types of experimental treatment or participated in a clinical study less than 28 days prior to this study.
• Pregnant or breastfeeding women. A negative pregnancy test is mandatory for fertile women.
• Fertile women, who do not wish to use safe contraception (e.g., birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid).
• Untreated bowel obstruction or massive gastrointestinal tumors verified by CT scan.
• Other present or previous malignant disease apart from curatively treated non-melanoma skin cancer or other types of cancer with minimal risk of relapse.
• CNS-metastases.
• Underlying medical disease not adequately treated (diabetes, cardiovascular disease).
• Uncontrolled hypertension (persistent BP > 150/100 despite antihypertensive treatment).
• Surgery incl. open biopsy less than 4 weeks before expected first dose of Bevacizumab.
• Patients with non-healing wounds or fractures.
• Previous cerebrovascular attack (TVA), transient ischaemic attack (TIA) or subarachnoidal bleeding (SAH) within last six months.
• Thromboembolic or haemorrhagic disease in the anamnesis.
• Clinically significant cardiovascular disease including Myocardial infarction or unstable angina less than 6 months prior to treatment

• New York heart Association NYHA class ≥ 2
• Poorly controlled cardial arrythmia despite medical treatment
• Peripheral vascular disease, grade 3 or above.
• Present or previous chronical use of Aspirin (less than 10 days before start of treatment) Aspirin > 325 mg daily.
• Present or recent use of full dose oral or parenteral anticoagulant or thrombolytic medicine.
• Preexisting neuropathy, sensoric or motoric ≥ grade 2.
• Decreased hearing.
• Bleeding tumor.
• Hypersensitivity to the active substance or one or more of the other substances contained in the protocol drugs.
• Hypersensitivity to products from ovarian cells (CHO) from Chinese hamster or other recombinant or humanized antibodies.