Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
406
Centre Hospitalier d'Aix-en-Provence
Aix-en-Provence, France
Hôpital de la Côte Basque
Bayonne, France
Institut Bergoniè
Bordeaux, France
Hôpital Fleyriat
Bourg-en-Bresse, France
Centre François Baclesse
Caen, France
Centre Hospitalier Intercommunal de Créteil
progression free survival
assessed by local Investigator
Time frame: 12 months
overall survival
Time frame: 12 months
number of complete or partial responses
according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: 6 months
worst grade toxicity per patient
according to Common Toxicity Criteria for Adverse Events v. 4.03
Time frame: evaluated every 3 weeks up to 12 months
number of patients taking oral antidiabetic therapy
Time frame: at baseline
number of patients taking antithrombotic therapy
Time frame: at baseline
progression free survival
as measured by independent central review
Time frame: 12 months
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Créteil, France
Centre d'Oncologie et de Radiothérapie
Dijon, France
Centre Georges Francois Leclerc
Dijon, France
Centre Hospitalier du Mans
Le Mans, France
Centre Hospitalier Universitaire Dupuytren
Limoges, France
...and 72 more locations