Ovarian Cancer Clinical Trial
Official title:
A Phase II Evaluation of Weekly Paclitaxel (NSC #673089) and Celecoxib (Celebrex®, NSC #719627) in the Treatment of Recurrent or Persistent Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop
tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of
cancer by stopping blood flow to the tumor and may increase the effectiveness of paclitaxel
by making tumor cells more sensitive to the drug. Giving celecoxib together with paclitaxel
may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with celecoxib
works in treating patients with recurrent or persistent platinum-resistant ovarian
epithelial or primary peritoneal cancer.
OBJECTIVES:
- Determine the antitumor activity of paclitaxel and celecoxib in patients with recurrent
or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and oral celecoxib twice
daily on days 2-6, 9-13, and 16-27. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22
months.
;
Masking: Open Label, Primary Purpose: Treatment
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