Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer



Status:Archived
Conditions:Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:March 2010

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Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel
is more effective when given alone or together with vandetanib.

PURPOSE: This randomized phase II trial is studying docetaxel given together with or without
vandetanib to see how well it works in treating patients with persistent or recurrent
ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


OBJECTIVES:

- To evaluate the clinical efficacy of docetaxel and vandetanib relative to docetaxel
alone in patients with platinum-resistant, recurrent, refractory, or
progressive/persistent ovarian epithelial, primary peritoneal, or fallopian tube
cancer, as measured by progression-free survival.

- To evaluate the response rate (complete and partial) and duration of overall survival
of these patients.

- To evaluate the response (complete and partial) and time to treatment failure after
treatment with single agent vandetanib following progression on single agent docetaxel.

- To evaluate the frequency and severity of adverse events as assessed by CTCAE v4.0.

- To evaluate the toxicity of single agent vandetanib following docetaxel as assessed by
CTCAE v4.0.

OUTLINE: Patients are stratified according to prior treatment with antiangiogenesis agents
(yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity. Patients who progress
also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in
the absence of a second disease progression or unacceptable toxicity.

- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once
daily on days 1-21. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.


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