S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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 Common Toxicity
           Criteria for Adverse Effects (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.
    

Intervention name(s): docetaxel; vandetanib
Intervention type(s): Drug; Drug
Intervention description(s): Given IV; Given orally
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; recurrent fallopian tube cancer; recurrent primary peritoneal cavity cancer