Cancer, Ovarian Clinical Trial
Official title:
A Randomized Phase II Multi-centric Open Label Clinical Trial to Determine the Efficacy and Toxicity of Preoperative Chemotherapy With or Without Bevacizumab in Patients With Advanced Ovarian Cancer
Recently results have shown that Bevacizumab is active both in monotherapy and in combination therapy in patients with ovarian cancer. One of our objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients.
Epithelial ovarian cancer (OC) is the fourth leading cause of cancer death in women, after
lung, breast and colon cancer, and it represents the most common cause of death from
gynaecological malignancies. The high mortality associated with OC is due to the lack of
screening tests that enable an early diagnosis, thus the majority of patients are diagnosed
at advanced stages of the disease when the chances of a cure are very limited. In fact, the
5-year overall survival (OS) rate for stage III-IV OC does not exceed 20-30% in many series.
The standard treatment for advanced OC is maximal cytoreductive surgery (or debulking)
followed by the administration of 6 cycles of adjuvant chemotherapy with carboplatin and
paclitaxel.
In recent years, a number of studies have been carried out with antiangiogenic drugs.
Specifically, bevacizumab, an anti-VEGF monoclonal antibody, has been shown to be active both
in monotherapy and combination therapy in patients with OC that have received multiple
previous lines of chemotherapy.
One of the objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves
the response and whether this affects the evolution of patients.
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