Ovarian Cancer Clinical Trial
Official title:
A Phase II Evaluation of AMG 706 (IND # 79,697) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
RATIONALE: AMG 706 may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well AMG 706 works in treating patients with
persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary
peritoneal cancer.
OBJECTIVES:
Primary
- To assess the activity of AMG 706, in terms of the frequency of patients with
progression-free survival for at least 6 months after initiating therapy or with an
objective tumor response, in patients with persistent or recurrent ovarian epithelial,
fallopian tube, or primary peritoneal carcinoma.
Secondary
- To determine the frequency and severity of adverse events as assessed by CTCAE v3.0.
- To characterize the distribution of the progression-free and overall survival of these
patients.
OUTLINE: This is a multicenter study.
Patients receive oral AMG 706 once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
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