Vandetanib to Treat Women With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Summary

Background: * Vandetanib is a drug that attacks a group of proteins on the surface of many cells, especially blood vessel cells and tumor cells. * Tumors require the development of new blood vessels in order to grow and spread. * In laboratory experiments, vandetanib slowed the growth of certain tumors and regulated their blood vessel growth. * In early clinical trials, some patients' tumors did not grow for a period of time while they were receiving vandetanib. Objectives: * To determine whether vandetanib can cause tumors to shrink or stabilize in some patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer. * To determine, by tumor biopsy, if features of the tumor change with vandetanib treatment may predict if the tumor will likely respond to vandetanib. Eligibility: * Women 18 years of age and older with ovarian, fallopian tube or primary peritoneal cancer that does not respond to standard treatment. Design: * Patients take vandetanib daily, by mouth in 28-day cycles until their disease worsens or they develop unacceptable side effects. * Tumor biopsies (surgical removal of a sample of tumor tissue) are done before starting vandetanib treatment and after 6 weeks of treatment. * Patients are followed in the clinic every 4 weeks during treatment for a physical examination, blood tests, and review of laboratory studies and side effects. * Patients have a computed tomography (CT) scan every 8 weeks to monitor tumor growth and magnetic resonance imaging (MRI) before starting vandetanib treatment, on the third day after taking vandetanib and 6 weeks into treatment. * Patients quality of life is assessed with regularly scheduled questionnaires.

Timeline

Start

2007-01

Primary completion

2008-12

Completion

2009-10

Publications

• Background Hollingsworth HC, Kohn EC, Steinberg SM, Rothenberg ML, Merino MJ. Tumor angiogenesis in advanced stage ovarian carcinoma. Am J Pathol. 1995 Jul;147(1):33-41.
• Background Spentzos D, Levine DA, Ramoni MF, Joseph M, Gu X, Boyd J, Libermann TA, Cannistra SA. Gene expression signature with independent prognostic significance in epithelial ovarian cancer. J Clin Oncol. 2004 Dec 1;22(23):4700-10. doi: 10.1200/JCO.2004.04.070. Epub 2004 Oct 25.
• Background Ryan AJ, Wedge SR. ZD6474--a novel inhibitor of VEGFR and EGFR tyrosine kinase activity. Br J Cancer. 2005 Jun;92 Suppl 1(Suppl 1):S6-13. doi: 10.1038/sj.bjc.6602603.
• Results Annunziata CM, Walker AJ, Minasian L, Yu M, Kotz H, Wood BJ, Calvo K, Choyke P, Kimm D, Steinberg SM, Kohn EC. Vandetanib, designed to inhibit VEGFR2 and EGFR signaling, had no clinical activity as monotherapy for recurrent ovarian cancer and no detectable modulation of VEGFR2. Clin Cancer Res. 2010 Jan 15;16(2):664-72. doi: 10.1158/1078-0432.CCR-09-2308. Epub 2010 Jan 12.

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