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PURPOSE: This phase II clinical trial is studying the side effects and how well EGEN-001 works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
- To estimate the proportion of patients who survive progression-free for ≥ 6 months and the proportion of patients who have objective tumor response (complete or partial) in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with intraperitoneal EGEN-001.
- To determine the frequency and severity of adverse events as assessed by the NCI CTCAE version 4.0.
- To determine the duration of progression-free survival and overall survival.
- To collect blood and peritoneal lavage fluid from patients that will be stored for future research.
OUTLINE: This is a multicenter study.
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Blood and peritoneal fluid samples may be collected at baseline for translational research.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Masking: Open Label, Primary Purpose: Treatment
Fallopian Tube Cancer
EGEN-001, laboratory biomarker analysis
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:13:54-0400
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