Phase II Open-Label Trial of Erlotinib (Tarceva) and Bevacizumab in Women With Advanced Ovarian Cancer
Erlotinib and bevacizumab, novel biologics, offer a new regimen for the treatment of ovarian
cancer in women who are refractory to standard drug regimens. Because bevacizumab is an
anti-angiogenesis drug and erlotinib is an EGFR receptor inhibitor their combination would
lead to the inhibition of multiple signal transduction pathways and the reversal of cancer
progression in this difficult to treat population. The study seeks to determine the
efficacy and safety of the EGFR receptor inhibitor, erlotinib plus the anti-angiogenesis
VEGF ligand inhibitor bevacizumab in women with platinum and taxane refractory ovarian
The study design is a non-randomized, open label, single center Phase II trial using a Simon
two stage design. Eligible patients are women who have a histologically or pathologically
confirmed diagnosis of epithelial carcinoma of the ovary or primary peritoneal carcinoma who
have relapsed or are refractory to therapy after primary treatment of their disease.
Patients will be treated with erlotinib 150 mg/day orally and bevacizumab 10mg/kg every two
weeks plus or minus one day intravenously. Forty patients will be enrolled in the study.
Initially 20 eligible patients will be accrued. If one or no confirmed response is
observed, the trial will be closed and the agents considered inactive. Otherwise, 20
additional eligible patients will be accrued for a total of 40 patients. Eight or more
responses out of 40 will be considered evidence warranting further study of the agents
provided other factors, such as progression-free and overall survival, also appear
Previous studies of this combination in non-small cell lung cancer, renal cell carcinoma and
metastatic breast cancer have indicated a potential synergistic effect for these two agents.
Preliminary data for the use of bevacizumab in advanced ovarian cancer indicates that this
agent has single-agent activity. As a result, the researchers are interested in exploring
the role of the combination of erlotinib and bevacizumab in advanced ovarian cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response (Complete Partial, Stable and Progression)
Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria
06.16.2005 to 10.05.2009
David S Alberts, MD
University of Arizona
United States: Institutional Review Board
|University of Arizona Cancer Center||Tucson, Arizona 85724|