Cervical Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and cisplatin, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with topotecan
and cisplatin works in treating patients with advanced, persistent, or recurrent cervical
cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
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