Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
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|ClinicalTrials.gov Identifier: NCT00003065|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
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 topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Biological: filgrastim Drug: paclitaxel Drug: topotecan hydrochloride||Phase 2|
- Determine the response, time to progression, disease free survival, and overall survival of patients with recurrent and/or metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel.
- Determine the feasibility and toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Filgrastim (G-CSF) is administered on days 6-14. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 weeks.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix|
|Study Start Date :||January 1997|
|Actual Study Completion Date :||February 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003065
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|Study Chair:||Amy D. Tiersten, MD||Herbert Irving Comprehensive Cancer Center|