Protocol Number: 07-C-0061

Title:

Phase II Study of Clinical Activity and Proteomic Pathway Profiling of the VEGFR2 Inhibitor, Vandetanib in Women With Relapsed or Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Number:

07-C-0061

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 or 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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Ovarian

VEGFR2

EGFR

Angiogenesis

Tyrosine Kinase

Protein Phosphorylation

Vandetanib

Recruitment Keyword(s):

Ovarian Cancer

Fallopian Tube Cancer

Peritoneal Cancer

Condition(s):

Ovarian Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Investigational Drug(s):

Zactima (Vandetanib)(ZD6474)

Investigational Device(s):

None

Interventions:

Drug: Zactima (Vandetanib)(ZD6474)

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

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.

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. Epub 2004 Oct 25. Erratum in: J Clin Oncol. 2005 Jan 1;23(1):248.

Ryan AJ, Wedge SR. ZD6474--a novel inhibitor of VEGFR and EGFR tyrosine kinase activity. Br J Cancer. 2005 Jun;92 Suppl 1:S6-13.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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