This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.
PRIMARY OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with bevacizumab and erlotinib. SECONDARY OBJECTIVES: I. Determine the toxic effects of this regimen in these patients. II. Determine the median progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
University of Chicago
Chicago, Illinois, United States
Response rate of patients treated with the combination of bevacizumab and OSI-774
Time frame: Up to 5 years
Progression-free survival
Will be analyzed using the Kaplan-Meier estimator (Kaplan 1958), and median progression-free survival times and their associated 90% confidence intervals will be determined using the method described in Brookmeyer and Crowley (Brookmeyer 1982).
Time frame: Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years
Median progression-free survival
Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
Time frame: From start of treatment to time of progression, assessed up to 5 years
Overall survival
Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
Time frame: Up to 5 years
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