Bevacizumab and Carboplatin for Patients With Ovarian Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00744718
- Lead Sponsor
- Vejle Hospital
- Brief Summary
This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 73
- 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.
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Patients who have received other types of experimental treatment or participated in a clinical study less than 28 days prior to this study.
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Pregnant or breastfeeding women. A negative pregnancy test is mandatory for fertile women.
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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).
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Untreated bowel obstruction or massive gastrointestinal tumors verified by CT scan.
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Other present or previous malignant disease apart from curatively treated non-melanoma skin cancer or other types of cancer with minimal risk of relapse.
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CNS-metastases.
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Underlying medical disease not adequately treated (diabetes, cardiovascular disease).
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Uncontrolled hypertension (persistent BP > 150/100 despite antihypertensive treatment).
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Surgery incl. open biopsy less than 4 weeks before expected first dose of Bevacizumab.
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Patients with non-healing wounds or fractures.
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Previous cerebrovascular attack (TVA), transient ischaemic attack (TIA) or subarachnoidal bleeding (SAH) within last six months.
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Thromboembolic or haemorrhagic disease in the anamnesis.
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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.
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Present or previous chronical use of Aspirin (less than 10 days before start of treatment) Aspirin > 325 mg daily.
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Present or recent use of full dose oral or parenteral anticoagulant or thrombolytic medicine.
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Preexisting neuropathy, sensoric or motoric ≥ grade 2.
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Decreased hearing.
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Bleeding tumor.
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Hypersensitivity to the active substance or one or more of the other substances contained in the protocol drugs.
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Hypersensitivity to products from ovarian cells (CHO) from Chinese hamster or other recombinant or humanized antibodies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Progression free survival From date of first treatment until date of verified progression or death. 12 months of follow-up
- Secondary Outcome Measures
Name Time Method Overall survival From date of first treatment until death. Up to 12 months Response rate Every 9 weeks until progression or death. Up to 12 months Response duration From date of first documented response until date of progression. Up to 12 months.
Trial Locations
- Locations (1)
Vejle Hospital
🇩🇰Vejle, Denmark