Vandetanib to Treat Women With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Status:
Terminated
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
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.