A Randomized, Open-label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable.
Inclusion Criteria:
- Adult female patients, >/= 18 years of age
- Histologically confirmed and documented high risk stage IIIC/IV epithelial ovarian
carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
- Patients are required to be deemed by a surgeon experienced in the management of
ovarian cancer not to be eligible for primary complete debulking surgery during a
laparoscopic procedure
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Life expectancy >/= 3 months
- Eligible for carboplatin and paclitaxel chemotherapy in accordance with local
standards
- Patient should be beneficiary of healthcare coverage under the social security system
Exclusion Criteria:
- Non-epithelial ovarian cancer, ovarian tumour with low malignant potential, or
mucinous and clear cell ovarian cancer
- Evidence of abdominal free air not explained by paracentesis or recent surgical
procedure
- Previous systemic therapy for ovarian cancer
- Previous exposure to mouse CA-125 antibody
- Current or recent treatment (within 28 days prior to Day 1, Cycle 1) with another
investigational drug or previous participation in this study
- Current or recent (within 10 days prior to first study drug dose) chronic daily
treatment with aspirin (>325 mg/day)
- Planned intraperitoneal cytotoxic chemotherapy
- Inadequate bone marrow, liver or renal function
- History of myocardial infarction, unstable angina, stroke or ischemic attack within 6
months prior to Day 1, Cycle 1
- Uncontrolled hypertension
- Clinically significant (i.e. active) cardiovascular disease (e.g. NYHA Class II or
greater congestive heart failure, aortic aneurism)
- Pre-existing peripheral neuropathy >/= CTC Grade 2
- Known hypersensitivity to bevacizumab or its excipients, Chinese hamster ovary cell
products or other recombinant humanized antibodies or to any planned chemotherapy
- Pregnant or lactating females
- History of other clinically active malignancy within 5 years of enrolment, except for
tumours with a negligible risk for metastasis or death, such as adequately controlled
basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
or breast