Status:
COMPLETED
Bevacizumab and Carboplatin for Patients With Ovarian Cancer
Lead Sponsor:
Vejle Hospital
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00744718
Start Date
August 1 2008
End Date
December 1 2015
Last Update
November 16 2016
Active Locations (1)
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1
Vejle Hospital
Vejle, Denmark, DK-7100