Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
|ClinicalTrials.gov Identifier: NCT00276796|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : May 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: cisplatin Drug: paclitaxel Drug: topotecan hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||January 2007|
- The frequency and duration of objective response
- The frequency and severity of observed adverse effects
- Progression-free survival and overall survival
- Prognostic factor: prior chemoradiation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276796
|Study Chair:||Harry J. Long, MD||Mayo Clinic|