Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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.
Drug: topotecan hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- The frequency and duration of objective response [ Designated as safety issue: No ]
- The frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
- Progression-free survival and overall survival [ Designated as safety issue: No ]
- Prognostic factor: prior chemoradiation [ Designated as safety issue: No ]
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276796
|Study Chair:||Harry J. Long, MD||Mayo Clinic|