Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Primary Peritoneal Cavity Cancer
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer|
|Study Start Date:||July 2001|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.