The purpose of this single arm, multicenter Phase II clinical trial was to assess the activity and tolerability of the combination of bevacizumab (Avastin®) and erlotinib (Tarceva®) in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer. Eligible patients received two or fewer prior chemotherapy regimens for recurrent or refractory disease and no prior anti-VEGF or anti-EGFR drugs. Between July and October 2005, 13 patients were enrolled.
There were two major objective responses — one complete response of 16+ month duration and one partial response of 11 month duration, representing an overall response rate of 15%. Two patients had fatal gastrointestinal perforations, and therefore, the study was discontinued. The trial investigators concluded that there was no strong suggestion that the Avastin®/Tarceva® combination was superior to single agent Avastin®, and noted that the rate of gastrointestinal perforation was of concern. The investigators believe that identification of risk factors for gastrointestinal perforation will be important with respect to the use of Avastin in the treatment of ovarian cancer.
[Source: “Efficacy and safety of bevacizumab plus erlotinib for patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer: A trial of the Chicago, PMH, and California Phase II consortia;” Nimeiri HS, et. al., Gynecol Oncol. 2008 Apr 17 (Epublication ahead of print).]