A Limited Access Phase II Trial of Weekly Topotecan (NSC #609699), Paclitaxel (NSC #673089), and Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
- Estimate the antitumor activity of the combination of paclitaxel, topotecan, and
cisplatin in patients with advanced, persistent, or recurrent carcinoma of the cervix.
- Determine the nature and degree of toxicity for this drug regimen in these patients.
- Determine the duration of progression-free survival and overall survival.
- Determine the impact of prior chemoradiation on response to treatment.
OUTLINE: This is an open-label study.
Patients receive paclitaxel IV over 1 hour followed by topotecan IV over 30 minutes and
cisplatin IV over 1 hour on days 1 and 8. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
The frequency and duration of objective response
Harry J. Long, MD
United States: Federal Government