A phase III study evaluating bevacizumab (Avastin) in combination with carboplatin and gemcitabine followed by continued use of bevacizumab alone until disease progression in women with recurrent, platinum-sensitive ovarian cancer, met its primary endpoint, according to a statement released by Genentech, a member of the Roche Group.

The study known as OCEANS is a multicenter, randomized, double-blind, placebo-controlled phase III trial in 484 women with platinum-sensitive recurrent ovarian, primary peritoneal or fallopian tube cancer.  The primary endpoint of the study was progression-free survival.  The secondary endpoints of the study included overall survival, objective response, duration of response, and safety.

Key Finding

According to the statement from Genentech, recently released data from the OCEANS study indicated that women who received a combination of bevacizumab (15 mg/kg every 3 weeks) and chemotherapy, followed by the continued use of bevacizumab alone, lived longer without their disease worsening, compared to women who received chemotherapy alone.

Women in OCEANS had received no more than one treatment regimen prior to enrollment in the trial. The results from this trial build on findings from two previous phase III studies (GOG 0218 and ICON7) in women with newly diagnosed ovarian cancer.  Both of these studies demonstrated that first-line bevacizumab in combination with carboplatin and paclitaxel, followed by the continued use of bevacizumab alone, significantly increased the time women with ovarian cancer lived without their disease getting worse, compared to those treated with chemotherapy alone.

No new safety findings were observed and adverse events were consistent with those seen in previous pivotal trials of bevacizumab. Serious adverse events associated with bevacizumab in previous trials include gastrointestinal perforation, surgical and wound-healing problems, and severe bleeding.

According to the statement, full data from the OCEANS study will be submitted for presentation at an upcoming medical meeting. ■