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

NCT00445549 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-06-26

Study results available
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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.

Conditions

  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms

Interventions

DRUG

Vandetanib

300 mg daily dose, 28 day cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Elise C Kohn, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-12-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00445549 on ClinicalTrials.gov