Primary Peritoneal Cavity Cancer Clinical Trial
Official title:
A Phase II Evaluation of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
PRIMARY OBJECTIVES:
I. Determine the 6-month progression-free survival of patients with persistent or recurrent
ovarian epithelial or primary peritoneal cancer treated with bevacizumab.
II. Determine the nature and degree of toxicity of this drug in these patients. III.
Determine the progression-free and overall survival of patients treated with this drug.
IV. Determine the frequency of clinical response in patients treated with this drug.
V. Determine the effect of this drug on initial performance status, age, and mucinous or
clear cell histology in these patients.
VI. Correlate biological and imaging markers with 6-month progression-free survival of
patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
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|---|---|---|---|
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