Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining tirapazamine with cisplatin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.
Primary Peritoneal Cavity Cancer
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin in Recurrent Platinum Sensitive Ovarian or Primary Peritoneal Cancer|
|Study Start Date:||June 2001|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of tirapazamine and cisplatin in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive tirapazamine IV over 2 hours followed 1 hour later by cisplatin IV over 30 minutes on day 1. Courses repeat every 3 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: A total of 20-65 patients will be accrued for this study.