Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase 2 Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the response rate and progression-free survival at 6 months in patients with
endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer.
II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients
with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer.
SECONDARY OBJECTIVES:
I. To collect blood and tumor specimens from all patients entered on the trial for possible
future analysis.
OUTLINE:
Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV
over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 years.
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