Following initial surgery (either debulking cytoreductive surgery or a biopsy if the patient has FIGO stage IV disease and there is no planned surgery before disease progression) patients with newly diagnosed FIGO stage I or IIa (Grade 3 or clear cell histology only), or FIGO stage IIb - IV (all grades and all histological types) epithelial ovarian, fallopian tube or primary peritoneal cancer, in whom no further surgery prior to disease progression is planned MedDRA version: 8.1 Level: LLT Cla
Conditions
Interventions
Trade Name: Avastin
Product Name: Bevacizumab
Product Code: RO4876646
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: bevacizumab
CAS Number: 216974-75-3
Current Spons
Sponsors
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age over 18 (as standard treatments not licensed for use in those under 18 years) - Written informed consent and able to comply with the protocol - Histologically confirmed high risk FIGO stage I and II a (grade 3 or clear cell histology), or FIGO stage IIb – IV (all grades, all histological types) epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer - Patients should have already undergone cytoreductive surgery and not be planned for any further surgical debulking prior to disease progression. Patients with stage IV disease in whom surgical debulking was not appropriate are eligible providing other criteria are fulfilled - Patients able to receive protocol treatment - ECOG performace status 0-2 - Life expectancy > 12 weeks - Patients fit enough to begin treatment within 6 weeks of surgery - Urine dipstick for proteinuria or = 2+, 24 hour urine must demonstrate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Non epithelial ovarian cancer or borderline tumours - Planned intraperitoneal therapy - Surgery (including open biopsy), or radiotherapy within the last 4 weeks prior to first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment - Malignancies other than ovarian cancer within 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer and/or early endometrial carcinoma - Uncontrolled hypertension - Previous CVA, TIA or sub arachnoid haemorrhage within 6 months prior to randomisation - MI or unstable angina within 6 months prior to randomisation - History of thrombotic or haemmorhagic disorder - Previous gastrointestinal perforation and/or clinical suspicion of frank or impending bowel obstruction - Current or recent (within 10 days of first dose of study treatment) use of aspirin > 325 mg/day - Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes (except for line patency)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether, in epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma, the addition of a specific new targeted anti-cancer treatment, bevacizumab, to the current international standard chemotherapy of carboplatin and paclitaxel, will improve progression free. Bevacizumab is a new type of treatment which works by interfering with the development of tumour blood vessels. It has already been licensed for use in combination with chemotherapy in colorectal cancer, and looks to have a promising role in other solid tumours. ;Secondary Objective: Secondary objectives of the trial include the effect of the addition of bevacizumab on overall survival of the patients, their response rates and duration of response. The trial will also assess the impact of the addition of bevacizumab on the safety and toxicity of the therapy, as well as any effects on the quality of life of the patients, both while recieving the treatment and afterwards. Also, as with any new and expensive drug therapy, the cost of any improvements in outcome are important to quantify and this study will incorporate an analysis of pharmacoeconomics. There will also be associated laboratory based 'translational research' studies aiming to further investigate molecular factors that may be predictors of response and/or prognosis. ;Primary end point(s): Progression-free Survival | — |
Countries
Denmark, Finland, France, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed